Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

November 13, 2020 updated by: Pieris Australia Pty Ltd

A Dose Escalating Single Blind Study to Assess the Safety, Tolerability and Pharmacokinetics of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRS-060 is a new drug being developed for treatment of asthma. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of PRS-060 in healthy subjects

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age
  • Body mass index (BMI) of 18-35
  • Subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml, at screening visit).

Exclusion Criteria:

  • History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subject's ability to participate in the study.
  • A history of drug or alcohol abuse.
  • History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for Interferon (INF)-y release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study.
  • Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period.
  • Subjects with any history of malignancy or neoplastic disease.
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator.
  • Subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function
  • Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function)
  • Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug.
  • Donation of 450 ml or more blood within the previous 12 weeks
  • Women who are pregnant
  • Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
PRS-060 Matching Placebo
Experimental: PRS-060
Drug: PRS-060
Drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events (AEs) after a single inhaled or IV infusion dose of PRS-060.
Time Frame: From time of dose until 30 days after dosing.
The number of participants with treatment related AEs as assessed by CTCAE v4.0. Subjects will be monitored for AEs during study participation (beginning at the time study drug is first administered) until 30 days after dosing.
From time of dose until 30 days after dosing.
Change in blood pressure.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess blood pressure (systolic and diastolic) as a criterion of safety and tolerability variables.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in heart rate.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in beats per minute (BPM) as a criterion of safety and tolerability variables.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in body temperature.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in body temperature as a criterion of safety and tolerability variables as measure in degrees Celsius.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in electrocardiograms (ECGs).
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in FEV1 (Forced expiratory volume 1-second)
Time Frame: Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours
To assess changes in FEV1 (Forced expiratory volume 1-second) as measured in L.
Pre-dose and post-dose at 5,10, 20 minutes,1 and 4 hours
Change in FEV6 (Forced expiratory volume 6-seconds)
Time Frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
To assess changes in FEV6 (Forced expiratory volume 6-seconds) as measured in L.
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Change in peak expiratory flow rate (PEFR)
Time Frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
To assess changes in PEFR (Peak expiratory flow rate) as measured in L/s.
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Change in forced vital capacity (FVC)
Time Frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
To assess changes in FVC (Forced vital capacity) as measured by a percentage (%) predicted.
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Change in sodium levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in sodium levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in potassium levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in potassium levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in chloride levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in chloride levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in bicarbonate levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in bicarbonate levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in blood urea nitrogen (BUN) / Urea levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in BUN/Urea levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in creatinine levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in creatinine levels as measured in umol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total protein levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total protein levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Changes in total albumin levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total albumin levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total ALP levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in ALP levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total ALT levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total ALT levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total AST levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total AST levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total bilirubin levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total bilirubin levels as measured in umol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total indirect bilirubin levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total indirect bilirubin levels as measured in umol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total amylase levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total amylase levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total lipase levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total lipase levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total uric acid levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total uric acid levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total creatine kinase (CK) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total CK levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total calcium levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total calcium levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total magnesium levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total magnesium levels as measured in mmol/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total lactate dehydrogenase (LDH) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total LDH levels as measured in U/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total immunoglobulin (IgG) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total IgG levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total immunoglobulin (IgA) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total IgA levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Changes in total immunoglobulin (IgE) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total IgE levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in total immunoglobulin (IgM) levels as part of standard serum chemistry panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total IgM levels as measured in g/L.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in hematocrit as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total hematocrit levels as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in red blood cell (RBC) counts as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in total red blood cell (RBC) counts as measured by 10^6/uL.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in platelet (PLT) counts as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in platelet counts as measured by 10^9/uL.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in white blood cell (WBC) counts as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in white blood cell (WBC) counts as measured by 10^3/uL.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in neutrophil percentage as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in neutrophil percentage as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in lymphocyte percentage as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in lymphocyte percentage as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in eosinophil percentage as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in eosinophil percentage as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in basophil percentage as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in basophil percentage as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in monocyte percentage as part of standard hematology panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in monocyte percentage as measured by %.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in clarity as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in clarity of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in specific gravity as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in specific gravity of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in pH as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in pH of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in protein levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in protein levels of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in glucose levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in glucose levels of the urine sample as measured by a positive or negative result.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in ketone levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in ketone levels of the urine sample as measured by a positive or negative result.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in blood levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in blood levels of the urine sample as measured by a positive or negative result.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in nitrite levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in nitrite levels of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.
Change in leukocyte esterase levels as part of a standard urinalysis panel.
Time Frame: Screening, day 1, day 2, day 3 and 30 days after dosing.
To assess changes in leukocyte esterase levels of the urine sample.
Screening, day 1, day 2, day 3 and 30 days after dosing.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK assessment: Cmax (observed maximum serum concentration taken directly from the individual concentration-time curve)
Time Frame: Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 10, 20 minutes,1 and 4 hours
PK assessment Tmax (Time to reach maximum serum concentration, taken directly from the individual concentration-time curve)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days)
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days)
PK assessment: t1/2 (Terminal half-life)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment: AUC(0-last) (Area under the serum concentration-curve from time zero to the time of last quantifiable analyte concentration)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment: AUC (Area under the concentration-time curve in the serum zero (pre-dose) extrapolated to infinite time)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment: AUC(0-24) (Area under the plasma concentration-curve)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment: Vz/F (Apparent volume of distribution during terminal phase)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment: CL/F (Apparent oral clearance estimated as dose divided by AUC)
Time Frame: Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
Evaluation of the PK of a single inhaled or IV infusion dose of PRS-060
Pre-dose and post-dose at 5, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 8,12,15,18, 36 and 48 hours and at 30 days
PK assessment of urine
Time Frame: Pre-dose and continuously during the following time-intervals: 0-4, 4-8, 8-12, 12-18, 18-24, 24-30, 30-36, 36-42 and 42-48 hours
Evaluation of PRS-060 levels in the urine after a single inhaled or IV infusion dose of PRS-060
Pre-dose and continuously during the following time-intervals: 0-4, 4-8, 8-12, 12-18, 18-24, 24-30, 30-36, 36-42 and 42-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pieris Australia Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Lickliter, MBBS PhD, Nucleus Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRS-060-PCS_06_17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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