RecruitingPhase 1NCT07596888

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

IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons With HIV-1 on Antiretroviral Therapy


Sponsor

University of North Carolina, Chapel Hill

Enrollment

30 participants

Start Date

Jun 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IAP086 0.3 mcg/kg, a drug called IAP086 1 mcg/kg, and others for people with hiv-1-infection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIAP086 0.3 mcg/kg

Single dose 0.3 mcg/kg IAP086 administered IV

DRUGIAP086 1 mcg/kg

Single dose 1 mcg/kg IAP086 administered IV

DRUGIAP086 3 mcg/kg

Single dose 3 mcg/kg IAP086 administered IV

DRUGIAP086 6 mcg/kg

Single dose 6 mcg/kg IAP086 administered IV

DRUGIAP086 10 mcg/kg

Single dose 10 mcg/kg IAP086 administered IV

DRUGIAP086 15 mcg/kg

Single dose 15 mcg/kg IAP086 administered IV

DRUGIAP086 25 mcg/kg

Single dose 25 mcg/kg IAP086 administered IV

DRUGIAP086 32 mcg/kg

Single dose 32 mcg/kg IAP086 administered IV

DRUGIAP086 40 mcg/kg

Single dose 40 mcg/kg IAP086 administered IV


Locations(1)

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT07596888


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