Study of a Human Bispecific Antibody VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults
- Conditions
- HIV Infection
- Interventions
- Biological: VRC-HIVMAB0121-00-AB
- Registration Number
- NCT06585891
- Brief Summary
Background:
HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immunodeficiency syndrome). Researchers want to find new ways to treat or prevent HIV infection. CAP256J3LS is a new product that uses antibodies. Antibodies are naturally occurring proteins; they target and disable disease-causing agents such as viruses. This new product may be able to stop HIV infections.
Objective:
To test the safety of CAP256J3LS in healthy people.
Eligibility:
People aged 18 to 60 years in good general health.
Design:
CAP256J3LS can be administered in 2 ways: (1) by a shot under the skin into the belly fat or (2) through a tube inserted into a vein in the arm. Participants will be divided into 6 groups: The study will open with the lowest dose of study product. The dose groups are spaced out to allow the study team to look over the safety data in each group. If there are no safety concerns in the lowest dose, then the next higher dose groups will be enrolled. This pattern will continue until all dose groups are enrolled. Also, some participants will receive only 1 dose; others will receive 3 doses, each spaced 12 weeks apart.
Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months. Those who get 3 doses will have 27 visits over 11 months. Participants will provide blood samples at each visit. Urine samples may also be needed.
All participants will get a thermometer and a measuring tool. They will measure any redness, swelling, or bruising they have at the injection site. They will check their temperature every day for 7 days after receiving the study drug. They will record their highest temperatures and any symptoms they have....
- Detailed Description
Design:
This first-in-human, Phase 1, open-label study will examine safety, tolerability, dose, and pharmacokinetics (PK) of CAP256J3LS (VRC-HIVMAB0121-00-AB) in healthy adults in a dose-escalation design. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256J3LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256J3LS will be detectable in human sera with a definable half-life.
Study Products:
The CAP256J3LS bispecific antibody (bsAb) targets the V2-apex and CD4-binding sites of the HIV-1 envelope. It is composed of the J3 camelid nanobody linked to CAP256V2LS through a 15 amino acid linker arm attached to the N-terminus of the CAP256V2LS light chain. The addition of the J3 nanobody adds a CD4-binding site directed neutralization functionality to the CAP256V2LS, which targets the V2 region of the HIV Env trimer. The bispecific antibody was developed by the VRC/NIAID/NIH 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.
Participants:
Healthy adults, 18-60 years of age
Study Plan:
This open-label study will include 6 groups to evaluate CAP256J3LS administered one time or by repeat dosing. Enrollment will begin with the 5 mg/kg dose groups, and enrollment for subsequent dose groups will proceed after dose-escalation safety reviews. Assessment of safety will include solicited reactogenicity and other adverse events, clinical observations, and monitoring of hematological and chemistry parameters at clinical visits throughout the study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 VRC-HIVMAB0121-00-AB 5 mg/kg IV- single administration Group 2 VRC-HIVMAB0121-00-AB 5 mg/kg SC- single administration Group 3 VRC-HIVMAB0121-00-AB 20 mg/kg IV- single administration Group 4 VRC-HIVMAB0121-00-AB 40 mg/kg IV- single administration Group 5 VRC-HIVMAB0121-00-AB 5 mg/kg SC- repeat dosing Group 6 VRC-HIVMAB0121-00-AB 20 mg/kg IV-repeat dosing
- Primary Outcome Measures
Name Time Method Safety and tolerability of CAP256J3LS ( 5 mg/kg SC) administered for for a total of 3 injections in 12 week intervals to healthy adults Through 24 weeks after last product administration To evaluate the safety and tolerability of a repeat SC dosing
Safety and tolerability of CAP256J3LS (5 mg/kg SC) administered to healthy adults Through 24 weeks after product administration To evaluate the safety and tolerability of a single SC dose
Safety and tolerability of CAP256J3LS ( 5mg/kg or 20mg/kg or 40 mg/kg IV) administered to healthy adults Through 24 weeks after product administration To evaluate the safety and tolerability of a single IV dose
Safety and tolerability of CAP256J3LS ( 20 mg/kg IV) administered for for a total of 3 injections in 12 week intervals to healthy adults Through 24 weeks after last product administration To evaluate the safety and tolerability of a repeat IV dosing
- Secondary Outcome Measures
Name Time Method PK will be evaluated at each dose level and route of administration Throughout the study To evaluate the pharmacokinetics of CAP256J3LS
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States