A Phase1 Study of VIB9600

Study Overview
=================
Brief Summary
-----------------
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Safety Issues

Intervention / Treatment
-----------------
* Biological: VIB9600
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A minimum of 56 subjects will be enrolled in 7 planned SAD cohorts (8 subjects per cohort). Subjects enrolled in SAD cohorts will be admitted to a Phase 1 unit and randomized to receive a single dose of VIB9600 or placebo administered by slow IV infusion or SC injection. A minimum of 16 subjects will be enrolled in 2 planned MAD cohorts (8 subjects per cohort). Subjects enrolled in the MAD cohorts will receive VIB9600 or placebo Q2W for 4 weeks (3 doses in total: one each on Days 1, 15 and 29).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIB9600<br>Single dose of VIB9600 administered by IV infusion or SC injection. Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks. | Biological: VIB9600<br>* 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).<br>|
| Placebo Comparator: Placebo<br>Placebo comparator administered by slow IV infusion or SC injection. | Drug: Placebos<br>* Placebo administered by slow IV infusion or SC injection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single and multiple doses of VIB9600 | Treatment-emergent adverse events that occur on or after the day of IP administration. | 113 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of VIB9600 following single- and multiple- dose administration | Concentration of VIB9600 in serum at different time points after IP administration. | SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113 | 
| Immunogenicity of VIB9600 following single- and multiple-dose administration. | Immunogenicity as measured by the presence of anti-drug antibodies (ADA) to VIB9600 | SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113 |