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Clinical trialNCT07596888RecruitingPhase 1Interventional

IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study

SponsorUniversity of North Carolina, Chapel HillEnrollment30HIV-1-infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age. People with HIV on ART with plasma HIV-1 RNA \< 50 copies/mL for 12 months prior to screening. Procedures (methods): The participant's standard of care ART regimen is continued throughout the study period. This study requires an overnight stay in a research unit. During the overnight stay, participants will receive a single infusion (medicine given slowly through a vein in their arm) of IAP086 and be monitored for 24 hours. Each later participant receives IAP086 at the same or a higher dose decided in advance. The dose will increase as more participants receive IAP086 without concerning side effects. Study visits also occur 2, 3, 7, 14, 21 and 28 days after the study drug is given. Study procedures include review of the medical history, physical exams, and blood draws.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of North Carolina

    Chapel Hill, North Carolina, United States

    Cynthia Gay, MD
    Recruiting
  • Duke Early Phase Clinical Research Unit

    Durham, North Carolina, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IAP086 0.3 mcg/kgIAP086 1 mcg/kgIAP086 10 mcg/kgIAP086 15 mcg/kgIAP086 25 mcg/kgIAP086 3 mcg/kgIAP086 32 mcg/kgIAP086 40 mcg/kgIAP086 6 mcg/kg
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 Jun 2026
Primary completion
31 May 2027
Completion
31 May 2027
Last update posted
17 Aug 2026
Registered enrollment
30
Registry id
NCT07596888

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.