A Phase 1 AVB-S6-500 Safety and Tolerability Study

August 7, 2018 updated by: Aravive, Inc.

A Single-blind, Randomized, Placebo-controlled, Phase 1, Single Ascending-dose and Repeat-dose, Safety and Tolerability Study of Intravenous AVB-S6-500 in Healthy Subjects

This is a randomized single-blind, placebo-controlled, Phase 1, single ascending dose (SAD) and repeat dose (RD), safety and tolerability study of AVB-S6-500 in healthy subjects. A SAD portion of the study consists of 4 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of AVB-S6-500. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (AVB-S6-500) or matching placebo.

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.

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.
43

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

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center

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 or female
  • Age 18 - 55
  • Body mass index (BMI) ranging between 18 and 30 kg/m2, inclusive
  • Negative urine drug screen/alcohol breathalyzer results at Screening and at Day -1
  • Has not used tobacco products during the 3 months prior to Screening and agrees to refrain from use throughout the study duration
  • Female subjects of child-bearing potential must agree to use one of the study-approved effective contraceptive methods for the duration of the study and through 1 month after completion of the final study visit
  • Male subjects must be either surgically sterilized or agree to use study-approved effective contraceptive methods for the duration of the study and through 1 month after completion of the final study visit
  • If female, a negative serum pregnancy test at Screening and urinary pregnancy test at Day -1 is required
  • Able to read, understand, and provide signed informed consent
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  • Blood pressure ≥ 140/90 mmHg or pulse > 100 beats/minute at Screening
  • QTc intervals corrected for heart rate via the Fridericia method (QTcF) > 450 msec (males) and > 480 msec (females) at Screening
  • Pregnant or a nursing female
  • Male with a pregnant partner
  • Currently enrolled in another clinical trial or has received treatment with an investigational drug during the 30 days (or 5 half-lives, whichever is longer) prior to dosing
  • History of substance or alcohol abuse or dependency within the past
  • Used any medications or over the-counter products within 14 days or 5 half lives (whichever is longer) prior to administration of study medication, including analgesics, hormonal contraceptives (oral contraceptive pills or implant), natural food supplements, or dietary or herbal supplements including vitamins)
  • Donated blood in excess of 500 mL within 56 days prior to the dosing or intention of donating during the study through the month after completing the study
  • Positive test results for hepatitis B virus (HBV) surface antigen, hepatitis C virus antibody (HCV), or human immunodeficiency virus (HIV)
  • History or presence of any condition that, in the opinion of the Investigator, could interfere with the study conduct or observation
  • A medical history of or any current clinically significant disorder, including but not limited to: asthma, angioedema, bronchospasm, ulcer disease, gastrointestinal bleeding, coagulation defects, hypertension, edema, heart failure, hypokalemia, cardiovascular disease, hypersensitivity reaction to any biologic drug, significant dermatologic diseases or condition that would significantly influence the immune response
  • A serious illness, medical surgical procedure, or trauma resulting in missed work or hospitalization within the 30 days preceding the beginning of study treatment
  • Received treatment for any type of cancer within the 5 years prior to enrollment
  • An employee, family member, or student of the Investigator or clinical site

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: SEQUENTIAL
  • 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.
EXPERIMENTAL: Single Ascending Dose - AVB-S6-500
Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo
Drug: AVB-S6-500
AVB-S6-500 is an investigational drug.
Other Names:
  • AVB500
PLACEBO_COMPARATOR: Single Ascending Dose - placebo
Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo
Other: Placebo
Matching placebo
EXPERIMENTAL: Repeat Dose - AVB-S6-500
Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo
Drug: AVB-S6-500
AVB-S6-500 is an investigational drug.
Other Names:
  • AVB500
PLACEBO_COMPARATOR: Repeat Dose - placebo
Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo
Other: Placebo
Matching placebo

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
Safety and tolerability of AVB-S6-500 - Adverse events
Time Frame: Up to 6 weeks
Monitoring of adverse events
Up to 6 weeks
Safety and tolerability of AVB-S6-500 - ECG
Time Frame: Up to 6 weeks
Monitoring of 12 lead ECGs
Up to 6 weeks
Safety and tolerability of AVB-S6-500 -physical examination
Time Frame: Up to 6 weeks
Physical examination of body systems
Up to 6 weeks
Safety and tolerability of AVB-S6-500 - vital sign
Time Frame: Up to 6 weeks
Vital sign measurment
Up to 6 weeks
Safety and tolerability of AVB-S6-500 - clinical laboratory assessments
Time Frame: Up to 6 weeks
Routine lab hematology, serum chemistry and coagulation
Up to 6 weeks

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
AUC
Time Frame: Up to 6 weeks
Area under the curve
Up to 6 weeks
Cmax
Time Frame: Up to 6 weeks
Maximum observed concentration
Up to 6 weeks
Ctrough
Time Frame: Up to 6 weeks
Serum concentration observed at end of a single dose and observed pre-dose during repeat doses
Up to 6 weeks
Tmax
Time Frame: Up to 6 weeks
Time to reach maximum observed plasma concentration
Up to 6 weeks
λz
Time Frame: Up to 6 weeks
Terminal phase elimination rate constant
Up to 6 weeks
t1/2
Time Frame: Up to 6 weeks
Terminal half-life
Up to 6 weeks
CL
Time Frame: Up to 6 weeks
The total body clearance
Up to 6 weeks
V
Time Frame: Up to 6 weeks
Volume of distribution
Up to 6 weeks
Pharmacodynamic parameter
Time Frame: Up to 6 weeks
Concentration of the drug target
Up to 6 weeks

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.
Aravive, Inc.

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.
January 31, 2018

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.
June 20, 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.
July 31, 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).
January 8, 2018

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.
January 16, 2018

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.
January 17, 2018

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.
August 9, 2018

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.
August 7, 2018

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.
August 1, 2018

More Information

Terms related to this study

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.
  • AVB500-HV-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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