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

NCT03401528 | Completed Phase 1 FDA Drug

• 1 other identifier: AVB500-HV-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• Safety and tolerability of AVB-S6-500 - Adverse events

  Monitoring of adverse events

  Up to 6 weeks

• Safety and tolerability of AVB-S6-500 - ECG

  Monitoring of 12 lead ECGs

  Up to 6 weeks

• Safety and tolerability of AVB-S6-500 -physical examination

  Physical examination of body systems

  Up to 6 weeks

• Safety and tolerability of AVB-S6-500 - vital sign

  Vital sign measurment

  Up to 6 weeks

• Safety and tolerability of AVB-S6-500 - clinical laboratory assessments

  Routine lab hematology, serum chemistry and coagulation

  Up to 6 weeks

Secondary Outcomes (9)

• AUC

  Up to 6 weeks

• Cmax

  Up to 6 weeks

• Ctrough

  Up to 6 weeks

• Tmax

  Up to 6 weeks

• λz

  Up to 6 weeks

Study Arms (4)

Single Ascending Dose - AVB-S6-500

EXPERIMENTAL

Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo

Drug: AVB-S6-500

Single Ascending Dose - placebo

PLACEBO COMPARATOR

Four sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo

Other: Placebo

Repeat Dose - AVB-S6-500

EXPERIMENTAL

Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo

Drug: AVB-S6-500

Repeat Dose - placebo

PLACEBO COMPARATOR

Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo

Other: Placebo

Interventions

AVB-S6-500 DRUG

AVB-S6-500 is an investigational drug.

Also known as: AVB500

Repeat Dose - AVB-S6-500; Single Ascending Dose - AVB-S6-500

Placebo OTHER

Matching placebo

Repeat Dose - placebo; Single Ascending Dose - placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aravive, Inc.: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

AVB-500 fusion protein

Study Officials

• Thomas C Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study has two portions: a single ascending dose (SAD) portion consisting of 4 sequential dose escalation cohorts, and a repeat dose (RD) portion. In both study portions, subjects are randomized to receive either a study intervention (AVB-S6-500) or a placebo.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 17, 2018
• Study Start: January 31, 2018
• Primary Completion: June 20, 2018
• Study Completion: July 31, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

US (1)