Title
A Phase1 Study of VIB9600
A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of VIB9600 by Intravenous Infusion or Subcutaneous Injection in Healthy Subjects
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600.
Part 1 (SAD): IV infusion (30, 100, 200, 300 or 1000 mg) or SC injection (300 mg) on Day 1. Part 2 (MAD): IV infusion (100 and 300 mg) every 2 weeks for 4 weeks (3 doses total; Days 1, 15 and 29).
Placebo administered by slow IV infusion or SC injection.
Key Inclusion Criteria: Healthy male and female subjects aged 18 through 65 years at the time of consent. Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg. Females must have been surgically sterilized. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit. Able and willing to comply with the requirements of the protocol. Key Exclusion Criteria: Concurrent enrollment in another clinical study involving an investigational treatment. Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1). Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned. History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening. Positive test for drugs of abuse. Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation. Receiving any of the prohibited concomitant medications: Any immunotherapy or immunosuppressive therapy Chronic use of steroid medications Immunoglobulin or blood products Live vaccines Anticoagulants Aspirin
