ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03401528
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Aravive Biologics

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AVB-S6-500 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Safety and tolerability of AVB-S6-500 - Adverse events [ Time Frame: Up to 6 weeks ]
    Monitoring of adverse events

  2. Safety and tolerability of AVB-S6-500 - ECG [ Time Frame: Up to 6 weeks ]
    Monitoring of 12 lead ECGs

  3. Safety and tolerability of AVB-S6-500 -physical examination [ Time Frame: Up to 6 weeks ]
    Physical examination of body systems

  4. Safety and tolerability of AVB-S6-500 - vital sign [ Time Frame: Up to 6 weeks ]
    Vital sign measurment

  5. Safety and tolerability of AVB-S6-500 - clinical laboratory assessments [ Time Frame: Up to 6 weeks ]
    Routine lab hematology, serum chemistry and coagulation


Secondary Outcome Measures :
  1. AUC [ Time Frame: Up to 6 weeks ]
    Area under the curve

  2. Cmax [ Time Frame: Up to 6 weeks ]
    Maximum observed concentration

  3. Ctrough [ Time Frame: Up to 6 weeks ]
    Serum concentration observed at end of a single dose and observed pre-dose during repeat doses

  4. Tmax [ Time Frame: Up to 6 weeks ]
    Time to reach maximum observed plasma concentration

  5. λz [ Time Frame: Up to 6 weeks ]
    Terminal phase elimination rate constant

  6. t1/2 [ Time Frame: Up to 6 weeks ]
    Terminal half-life

  7. CL [ Time Frame: Up to 6 weeks ]
    The total body clearance

  8. V [ Time Frame: Up to 6 weeks ]
    Volume of distribution

  9. Pharmacodynamic parameter [ Time Frame: Up to 6 weeks ]
    Concentration of the drug target



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401528


Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Aravive Biologics
Investigators
Principal Investigator: Thomas C Marbury, MD Orlando Clinical Research Center

Responsible Party: Aravive Biologics
ClinicalTrials.gov Identifier: NCT03401528     History of Changes
Other Study ID Numbers: AVB500-HV-001
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No