A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015

December 6, 2022 updated by: Pulmongene Ltd.

A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).

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

Participants will be enrolled and randomized into 1 of 7 cohorts in a double-blind manner.

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.
54

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Centre

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male or non-pregnant, non-lactating female volunteers, between 18 and 60 years of age, inclusive at the time of informed consent.
  2. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (inclusive) and body weight between 50 and 100 kg for males and between 45 and 100 kg for females.
  3. No clinically significant clinical laboratory values (Hematology, coagulation, biochemistry and urinalysis) at the discretion of the PI.
  4. Females of child bearing potential must use an acceptable, highly effective double contraception and have a negative pregnancy test at Screening and Day-1.
  5. Documented evidence of surgical sterilization at least 6 months prior to screening for women or vasectomy at least 90 days prior to screening.
  6. Women not of child bearing potential must be menopausal for >/= 12 months.
  7. Males must not donate sperms for at least 90 days after PMG1015 administration.

Exclusion Criteria:

  1. History or evidence of clinically significant condition, including but not limited to any cardiovascular, gastrointestinal, endocrinologic, hematologic, psychiatric, renal disease, musculoskeletal, infectious, or neurological condition or any chronic medical condition and/or other major disease, as determined by the PI.
  2. A PR < 40 or > 100 beats per minute, mean systolic blood pressure (SBP) > 140 mmHg, or mean diastolic blood pressure (DBP) > 95 mmHg .
  3. A mean corrected QT interval using Fridericia's formula (QTcF) interval at Screening > 450 ms in males and > 470 ms in females. If the mean QTcF exceeds these limits, one additional triplicate ECG will be performed.
  4. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the PI, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T wave morphology or left ventricular hypertrophy.
  5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine > 1.5 × the upper limit of the normal range (ULN) or total bilirubin or lymphocyte counts > ULN.
  6. Participants with a positive toxicology screening panel or alcohol breath test on Screening/Day-1.
  7. Participants with a history of substance abuse or dependency or history of recreational IV drug use over the last 2 years.
  8. Plasma donation/Blood donation or significant blood loss within 60 days prior to the first IP administration.
  9. Use of any IP (including other investigational mAb products) or investigational medical device within 30 days prior to Screening or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to screening.
  10. Major surgery (general anesthetic) within 3 months or minor surgery (local anesthetic) within 1 month prior to IP administration, or planned surgery during the study period, which is determined by the PI to be clinically relevant.
  11. Fever or symptomatic bacterial or viral infection.
  12. Participants who have received live vaccines or attenuated vaccines within 1 month before dosing.
  13. Participants with any active malignancy or history of malignancy within 5 years prior to enrolment.
  14. Use of any other prescription medications.
  15. History of anaphylaxis, allergic reactions to the excipients of IP, asthma.
  16. Positive blood screen for HIV1/2 antibody, Hepatitis B surface antigen, hepatitis C virus, or syphilis at screening.
  17. Participants with an inability to tolerate venous access.
  18. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
  19. An employee of Pulmongene or Novotech (Australia) Pty Ltd.
  20. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and while resident at the CRU.
  21. Any other condition or finding that in the opinion of the PI or designee would put the participant or study conduct at risk.

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: Double

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.
Experimental: Single Ascending Doses Cohort 1a
Subjects will receive either Dose level 1 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 1
Dose level 1 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1b
Subjects will receive either Dose level 2 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 2
Dose level 2 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1c
Subjects will receive either Dose level 3 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 3
Dose level 3 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1d
Subjects will receive either Dose level 4 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 4
Dose level 4 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1e
Subjects will receive either Dose level 5 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 5
Dose level 5 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1f
Subjects will receive either Dose level 6 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 6
Dose level 6 of PMG1015
Other Names:
  • PMG1015
Experimental: Single Ascending Doses Cohort 1g
Subjects will receive either Dose level 7 of PMG1015 or Placebo
Drug: Placebo
Placebo to match
Drug: PMG1015 Dose 7
Dose level 7 of PMG1015
Other Names:
  • PMG1015

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
The incidence of Treatment-emergent adverse events (TEAEs)
Time Frame: Day 1-Day 85
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.
Day 1-Day 85
The severity of Treatment-emergent adverse events (TEAEs)
Time Frame: Day 1-Day 85
TEAEs are AEs that occur following the start of treatment.
Day 1-Day 85
The incidence of Serious adverse events (SAEs)
Time Frame: Day 1-Day 85
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Day 1-Day 85
The severity of Serious adverse events (SAEs)
Time Frame: Day 1- Day 85
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Day 1- Day 85
Number of participants with abnormally clinical vital signs
Time Frame: Day 1- Day 85
Vital signs include pulse rate (PR), blood pressure (BP), respiratory rate (RR) and tympanic temperature (T)
Day 1- Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time Frame: Day 1-Day 85.
All ECG tracings will be reviewed by the PI or designee and assessed for clinical significance.
Day 1-Day 85.
Number of participants with abnormal clinically significant clinical laboratory results
Time Frame: Day 1- Day 85
Clinical laboratory test include hematology, coagulation, biochemistry, and urinalysis.
Day 1- Day 85
MTD of PMG1015 in healthy participants
Time Frame: Day 1- Day 85
Maximum tolerated dose of PMG1015 in healthy participants
Day 1- Day 85
Number of patients with abnormal clinically significant results from physical examination
Time Frame: Day 1-Day 85
Complete physical examination include, general appearance, head, eyes, ears, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Day 1-Day 85

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
Area under the serum-concentration time curve (AUC) from time zero (from the start of infusion time) to the last time point with measurable analyte concentration (AUC0-t)
Time Frame: Day 1-Day 85.
Area under the plasma concentration versus time curve (AUC) from time 0 to time of last quantifiable concentration
Day 1-Day 85.
AUC from time zero to infinity (AUC0-∞)
Time Frame: Day 1-Day 85.
Area under the plasma concentration versus time curve (AUC) from time 0 (from the start of infusion) extrapolated to infinity
Day 1-Day 85.
To determine %AUCexp
Time Frame: Day 1-Day 85.
The percentage of the AUC that has been extrapolated beyond the last observed data point
Day 1-Day 85.
To determine Cmax
Time Frame: Day 1-Day 85.
Maximum observed serum PMG1015 concentration
Day 1-Day 85.
To determine Tmax, derived from serum concentration of each dose of PMG1015
Time Frame: Day 1-Day 85.
Time to maximum observed concentration
Day 1-Day 85.
To determine t1/2
Time Frame: Day 1-Day 85.
Terminal elimination half life summarized by dosing regimen
Day 1-Day 85.
Apparent total body clearance (CL)
Time Frame: Day 1-Day 85.
CL is the measure of the rate at which a drug is metabolized or eliminated by normal biological processes
Day 1-Day 85.
Apparent volume of distribution during the terminal phase (Vz)
Time Frame: Day 1-Day 85.
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Day 1-Day 85.
Apparent terminal elimination rate constant (λz or kel)
Time Frame: Day 1-Day 85.
λz is calculated using log-linear regression of the terminal portions of the plasma concentrations versus time curves.
Day 1-Day 85.
Levels of ADA
Time Frame: Day 1-Day 85
Anti-drug antibody levels in blood
Day 1-Day 85

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.
Pulmongene 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: Richard Friend, 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.
October 14, 2021

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.
August 10, 2022

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.
August 10, 2022

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).
August 20, 2021

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.
August 20, 2021

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.
August 26, 2021

Study Record Updates

Last Update Posted (Estimate)

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.
December 8, 2022

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.
December 6, 2022

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.
December 1, 2022

More Information

Terms related to this study

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.
  • PMG1015-AUS-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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