Testing a new bispecific antibody for HIV in healthy adults

VRC 617: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety and Pharmacokinetics of a Human Bispecific Antibody, VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

This study is testing a new antibody for HIV in healthy adults to see if it's safe and how well their bodies handle it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06585891 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial aims to evaluate the safety and tolerability of a bispecific antibody, CAP256J3LS, in healthy adults aged 18 to 60. Participants will receive the antibody either intravenously or subcutaneously, with the study designed to escalate doses based on safety data. The trial will assess how well the antibody is tolerated and its pharmacokinetics in the human body. The study is structured to ensure that safety is monitored closely as participants progress through different dose groups.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 60 years without significant medical histories.

Not a fit: Patients with existing health conditions or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new preventive strategies against HIV infection.

How similar studies have performed: While this approach is novel, similar studies targeting HIV have shown promise in the past.

Eligibility criteria

* INCLUSION CRITERIA:

A participant must meet all of the following criteria:

1. Willing and able to complete the informed consent process.
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
3. Available for clinical follow-up through the last study visit.
4. 18 to 60 years of age.
5. In good general health without a clinically significant medical history.
6. Physical examination without clinically significant findings within the 56 days prior to enrollment.
7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to a SC group.
8. Willing to have blood samples collected, stored indefinitely, and used for research purposes.

   Laboratory Criteria within 56 days prior to enrollment:
9. White blood cell count (WBC): 2,500-12,000/mm\^3.
10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval, excluding absolute lymphocyte count which must not be lower than normal range.
11. Platelets: 125,000 - 400,000/mm\^3.
12. Hemoglobin within institutional normal range or is lower than normal range but does not meet Grade 1 criteria and is not clinically concerning.
13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN).
14. ALT: \<= ULN.
15. AST: \<= ULN.
16. ALP: \<= ULN.
17. Total bilirubin within institutional normal range or is outside normal range but does not meet Grade 1 criteria and is not clinically concerning
18. Direct bilirubin: \<= ULN
19. Negative HIV 1/2 Antibody/Ag test.

    Female-Specific Criteria:
20. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
21. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

EXCLUSION CRITERIA:

A participant will be excluded if one or more of the following conditions apply:

1. Woman who is breast-feeding or planning to become pregnant during study participation.
2. Weight \> 115 kg.
3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
4. Hypertension that is not well controlled.
5. Receipt of any investigational study product within 28 days prior to enrollment.
6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
7. Receipt of any live attenuated vaccine within 28 days prior to enrollment.
8. Receipt of any vaccine within 2 weeks prior to enrollment.
9. Known history of Gilbert's syndrome.
10. Known history of kidney or liver disease.
11. Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes.
12. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within 14 days prior to enrollment.
13. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
14. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to diabetes mellitus, hepatitis, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, cancer and clinically significant forms of drug or alcohol abuse.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Joseph P Casazza, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: VRC Clinic

Conditions HIV Infection; Immune Response; HIV; Bi-Specific Antibody