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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07596888
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • IAP086 0.3 mcg/kg — DRUG
    Single dose 0.3 mcg/kg IAP086 administered IV
  • IAP086 1 mcg/kg — DRUG
    Single dose 1 mcg/kg IAP086 administered IV
  • IAP086 3 mcg/kg — DRUG
    Single dose 3 mcg/kg IAP086 administered IV
  • IAP086 6 mcg/kg — DRUG
    Single dose 6 mcg/kg IAP086 administered IV
  • IAP086 10 mcg/kg — DRUG
    Single dose 10 mcg/kg IAP086 administered IV
  • IAP086 15 mcg/kg — DRUG
    Single dose 15 mcg/kg IAP086 administered IV
  • IAP086 25 mcg/kg — DRUG
    Single dose 25 mcg/kg IAP086 administered IV
  • IAP086 32 mcg/kg — DRUG
    Single dose 32 mcg/kg IAP086 administered IV
  • IAP086 40 mcg/kg — DRUG
    Single dose 40 mcg/kg IAP086 administered IV

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1
    Each participant will receive a single IV infusion of 0.3 mcg/kg IAP086 on Day 0.
  • Other: Cohort 2
    Each participant will receive a single IV infusion of 1 mcg/kg IAP086 on Day 0.
  • Other: Cohort 3
    Each participant will receive a single IV infusion of 3 mcg/kg IAP086 on Day 0.
  • Other: Cohort 4
    Each participant will receive a single IV infusion of 6 mcg/kg IAP086 on Day 0.
  • Other: Cohort 5
    Each participant will receive a single IV infusion of 10 mcg/kg IAP086 on Day 0.
  • Other: Cohort 6
    Each participant will receive a single IV infusion of 15 mcg/kg IAP086 on Day 0.
  • Other: Cohort 7
    Each participant will receive a single IV infusion of 25 mcg/kg IAP086 on Day 0.
  • Other: Cohort 8
    Each participant will receive a single IV infusion of 32 mcg/kg IAP086 on Day 0.
  • Other: Cohort 9
    Each participant will receive a single IV infusion of 40 mcg/kg IAP086 on Day 0.

Primary Outcome Measure

Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment [ Time Frame: From first dose of study treatment through Day 28/end of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27514
Susan Pedersen
[email protected]
919-966-6713
Cynthia Gay, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina· Chapel Hill, NC

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