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

NCT07596888 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

IAP086 0.3 mcg/kg

Single dose 0.3 mcg/kg IAP086 administered IV

DRUG

IAP086 1 mcg/kg

Single dose 1 mcg/kg IAP086 administered IV

DRUG

IAP086 3 mcg/kg

Single dose 3 mcg/kg IAP086 administered IV

DRUG

IAP086 6 mcg/kg

Single dose 6 mcg/kg IAP086 administered IV

DRUG

IAP086 10 mcg/kg

Single dose 10 mcg/kg IAP086 administered IV

DRUG

IAP086 15 mcg/kg

Single dose 15 mcg/kg IAP086 administered IV

DRUG

IAP086 25 mcg/kg

Single dose 25 mcg/kg IAP086 administered IV

DRUG

IAP086 32 mcg/kg

Single dose 32 mcg/kg IAP086 administered IV

DRUG

IAP086 40 mcg/kg

Single dose 40 mcg/kg IAP086 administered IV

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cynthia Gay, MD · UNC Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596888 on ClinicalTrials.gov