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NCT07596888 · ClinicalTrials.gov registry record · Phase 1
IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07596888 is a Phase 1 study that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 30 participants.
The verdict
NCT07596888, a Phase 1 study, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG IAP086 0.3 mcg/kg
- DRUG IAP086 1 mcg/kg
- DRUG IAP086 3 mcg/kg
- DRUG IAP086 6 mcg/kg
- DRUG IAP086 10 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06-18 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07596888
The ClinicalTrials.gov registry entry for NCT07596888 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which IAP086 0.3 mcg/kg is the first listed.
NCT07596888 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07596888 about?
NCT07596888 is a clinical study titled "IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study". 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): ...
What is the current status of trial NCT07596888?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-06-18. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07596888?
The interventions under investigation include: IAP086 0.3 mcg/kg (DRUG), IAP086 1 mcg/kg (DRUG), IAP086 3 mcg/kg (DRUG), IAP086 6 mcg/kg (DRUG), IAP086 10 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT07596888?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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