Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serious adverse events (SAEs) will be collected from treatment initiation through Day 28/end of study. SAEs are defined according to standard regulatory criteria (e.g., events that result in death, are life threatening, require or prolong hospitalization, result in persistent or significant disability/incapacity, or are otherwise medically important). This outcome includes only SAEs assessed by the study team as at least possibly related to study treatment (possibly or definitely related). Abnor
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 |
What NCT07596888 shows while recruiting
NCT07596888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which IAP086 0.3 mcg/kg is the first listed.
NCT07596888 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07596888's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI