New antibody shot could block HIV – first human safety test underway

NCT ID NCT06585891

Completed Prevention Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests the safety of a new antibody called CAP256J3LS in 24 healthy adults aged 18 to 60. The antibody is designed to target and neutralize HIV. Participants receive either one or three doses, given as a shot under the skin or through an IV. The study monitors side effects and how long the antibody stays in the body.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CAP256J3LS (a bispecific antibody that targets HIV)
What this could lead to: If successful, this could pave the way for a new HIV prevention or treatment approach using antibodies instead of daily pills.
What could go wrong: This is an early Phase 1 safety trial with only 24 healthy participants, so it is too soon to know if the antibody will effectively prevent or treat HIV in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV INFECTION

Contacts and locations

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.