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
University of North Carolina, Chapel Hill
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.
Description
This is a phase 1, open-label, dose-escalation, study of IAP086 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to characterize the safety, tolerability, and pharmacokinetics (PK) of the study drug in healthy PWH suppressed on ART. The participant's standard of care ART regimen is continued throughout the study period. The study will evaluate single ascending doses of IAP086 with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9. Given the focus of this study is on safety, accrual within a dose cohort will be staggered such that each par…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures 2. Able and willing to provide adequate locator information 3. Able and willing to comply with all study requirements through Day 28 4. Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans 5. Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent 6. HIV infection documented by any licensed rapid HIV test or HIV enzyme or c…
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 (2)
- University of North CarolinaChapel Hill, North Carolina
- Duke Early Phase Clinical Research UnitDurham, North Carolina