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

NCT07596888 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 25-2299
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

HIV-1-infection

Keywords

HIV-1 on Antiretroviral Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment

  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). Abnormal laboratory values or vital signs are included only if they meet SAE criteria. Non serious adverse events are summarized separately.

  From first dose of study treatment through Day 28/end of study

• Number of Grade 3 or Greater (Severe) Adverse Events (AEs) that are at least possibly related to study treatment

  This outcome measures the number of Grade 3 or Greater (Severe) Adverse Events (AEs) that will be collected from treatment initiation through Day 28/end of study. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (The Division of AIDS (DAIDS) AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening.

  From first dose of study treatment through Day 28/end of study

• Number of Adverse Events (AEs) that are at least possibly related to study treatment

  Adverse events (AEs) will be collected from treatment initiation through Day 28/end of study. AEs are defined according to standard regulatory criteria (e.g., any unfavorable, unintended medical occurrence (sign, symptom or disease) temporally associated with the use of the investigational product, regardless of whether it is considered related to the treatment. This outcome includes only AEs assessed by the study team at least possibly related to study treatment (possibly or definitely related) Non serious adverse events are summarized under overall safety/AE outcome.

  From first dose of study treatment through Day 28/end of study

• Proportion of participants who prematurely discontinue IAP086 study treatment due to Adverse Events (AEs) or Serious Adverse Events (SAEs) that are at least possibly related to study treatment

  Safety data will include signs and symptoms, diagnoses, clinically significant laboratory abnormalities, and clinically significant abnormal vital signs that lead to premature discontinuation of study treatment. Relationship to study treatment will be assessed by the study team using the categories not related, possibly related, or definitely related. This outcome measure assesses the proportion of participants who permanently discontinue IAP086 study treatment due to an adverse event (AE) or serious adverse event (SAE) that is assessed as at least possibly related to study treatment. AEs and SAEs include clinical events, laboratory abnormalities, or abnormal vital signs that result in treatment discontinuation. Relationship to study treatment will be assessed by the study team as not related, possibly related, or definitely related.

  From first dose of study treatment through Day 28/end of study

Secondary Outcomes (5)

• Mean Area Under the Concentration-time Curve (AUC)

  Pre-infusion through 24-hours post-end of infusion

• Mean Maximum Concentration (Cmax) of IAP086

  Pre-infusion through 24-hours post-end of infusion

• Mean Time to Maximal Concentration (Tmax) of IAP086

  Pre-infusion through 24-hours post-end of infusion

• Mean Concentration at 24 hours post-IAP086 (C24)

  Pre-infusion through 24-hours post-end of infusion

• Mean Terminal Half-life of IAP086

  Pre-infusion through 24-hours post-end of infusion

Study Arms (9)

Cohort 1

OTHER

Each participant will receive a single IV infusion of 0.3 mcg/kg IAP086 on Day 0.

Drug: IAP086 0.3 mcg/kg

Cohort 2

OTHER

Each participant will receive a single IV infusion of 1 mcg/kg IAP086 on Day 0.

Drug: IAP086 1 mcg/kg

Cohort 3

OTHER

Each participant will receive a single IV infusion of 3 mcg/kg IAP086 on Day 0.

Drug: IAP086 3 mcg/kg

Cohort 4

OTHER

Each participant will receive a single IV infusion of 6 mcg/kg IAP086 on Day 0.

Drug: IAP086 6 mcg/kg

Cohort 5

OTHER

Each participant will receive a single IV infusion of 10 mcg/kg IAP086 on Day 0.

Drug: IAP086 10 mcg/kg

Cohort 6

OTHER

Each participant will receive a single IV infusion of 15 mcg/kg IAP086 on Day 0.

Drug: IAP086 15 mcg/kg

Cohort 7

OTHER

Each participant will receive a single IV infusion of 25 mcg/kg IAP086 on Day 0.

Drug: IAP086 25 mcg/kg

Cohort 8

OTHER

Each participant will receive a single IV infusion of 32 mcg/kg IAP086 on Day 0.

Drug: IAP086 32 mcg/kg

Cohort 9

OTHER

Each participant will receive a single IV infusion of 40 mcg/kg IAP086 on Day 0.

Drug: IAP086 40 mcg/kg

Interventions

IAP086 0.3 mcg/kg DRUG

Single dose 0.3 mcg/kg IAP086 administered IV

Cohort 1

IAP086 1 mcg/kg DRUG

Single dose 1 mcg/kg IAP086 administered IV

Cohort 2

IAP086 3 mcg/kg DRUG

Single dose 3 mcg/kg IAP086 administered IV

Cohort 3

IAP086 6 mcg/kg DRUG

Single dose 6 mcg/kg IAP086 administered IV

Cohort 4

IAP086 10 mcg/kg DRUG

Single dose 10 mcg/kg IAP086 administered IV

Cohort 5

IAP086 15 mcg/kg DRUG

Single dose 15 mcg/kg IAP086 administered IV

Cohort 6

IAP086 25 mcg/kg DRUG

Single dose 25 mcg/kg IAP086 administered IV

Cohort 7

IAP086 32 mcg/kg DRUG

Single dose 32 mcg/kg IAP086 administered IV

Cohort 8

IAP086 40 mcg/kg DRUG

Single dose 40 mcg/kg IAP086 administered IV

Cohort 9

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures
• Able and willing to provide adequate locator information
• Able and willing to comply with all study requirements through Day 28
• 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
• Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent
• HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.
• NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all Investigational New Drug (IND) studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.
• Plasma HIV-1 RNA viral load must meet the following conditions:
• \< 50 copies/mL at 2 time points within 12 months prior to screening
• \< 50 copies/mL at screening
• Not \> 1000 copies/mL at any time within 6 months prior to screening
• On continuous ART for at least 24 months prior to screening and must continue ART throughout the study. Permitted ART regimens include:
• At least 3 ART drugs, one ART drug must include an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz excluded (see 5.2) or
• At least 2 ART drugs including injectables, in which one drug is an integrase inhibitor that is FDA approved or recommended by Department of Health and Human Services Treatment Guidelines.
• NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.

You may not qualify if:

• Current use of moderate or strong CYP3A inhibitors or inducers for any indication including current use of a protease inhibitor, ritonavir, cobicistat, or efavirenz as part of ART regimen (See Section 6.1.1)
• Significant history or presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological disorders, immunodeficiency other than HIV-1, or clinical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
• Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
• Daily steroid or long-acting beta-agonist prevention
• Hospitalization in the last two years
• Clinically significant cardiovascular disease within 12 months prior to screening including but not limited to:
• Myocardial infarction or unstable angina
• Cardiac arrhythmias
• Uncontrolled hypertension at screening: systolic blood pressure \> 180 mmHg, diastolic blood pressure \>100 mmHg that is sustained on repeat measurement (without intervention)
• Cerebrovascular accident
• Congestive heart failure, New York Heart Association class II-IV
• QTc \>450 msec at screening NOTE: QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read
• Diabetes mellitus ≥ Grade 3 per DAIDS criteria (defined as uncontrolled despite treatment modification or hospitalization for immediate glucose control indicated)
• Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral antibiotic, antiviral, or antifungal treatment within 14 days prior to the initiation of study drug.
• History of coagulopathy or other bleeding disorder or current or anticipated need for chronic anti-coagulation

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

• Cynthia Gay, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Pedersen

CONTACT

9199666713; susan_pedersen@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label dose escalation design. Single Ascending Dose. Where the treatment dose is gradually increased in the cohorts

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months after publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Locations

US (1)