Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
HIV
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

Design: This first-in-human, open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP25...

Design: This first-in-human, open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256V2LS will be detectable in human sera with a definable half-life. Study Product: The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS Programme of Research in South Africa (CAPRISA) and is manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use 10 mL glass vials. R-Gene 10 will be added as a stabilizing agent to IV doses of CAP256V2LS. R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine Hydrochloride, USP in Water for Injection (equivalent to a 10% solution). Subjects: Healthy subjects, 18-60 years of age Study Plan: This open-label study will include 2 dosing regimens with CAP256V2LS administered at 5 mg/kg IV and 5 mg/kg SC. A single dose of the study product will be administered on Day 0 as shown below. VRC 611 Study Design Group 1 Study Product: CAP256V2LS Subjects per Group: 5 Dose (mg/kg) and Route Administered: 5 mg/kg IV Day 0: X Group 2 Study Product: CAP256V2LS Subjects per Group: 5 Dose (mg/kg) and Route Administered: 5 mg/kg SC Day 0: X Total Subjects: 10 (Enrollment up to 20 subjects is permitted in case additional evaluations for safety or pharmacokinetic (PK) evaluations are needed.) Duration: Study participation will be approximately 24 weeks from the Day 0 product administration

Tracking Information

NCT #
NCT04408963
Collaborators
Not Provided
Investigators
Principal Investigator: Alicia T Widge, M.D. National Institute of Allergy and Infectious Diseases (NIAID)