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

Recruiting now · Phase 1

Conditions studied: HIV-1-infection

In brief

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 facts

Study ID

NCT07596888

Run by

University of North Carolina, Chapel Hill

People needed

30

Starts

2026-06-18

Expected to finish

2027-05-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.
• NOTE: No changes or modifications of ART dosing allowed within 30 days prior to screening.
• CD4 cell count > 350 cells/mm3 at screening
• Hepatitis C virus (HCV) antibody negative or HCV RNA negative at screening
• Hepatitis B surface antigen negative at screening
• Clinical laboratory parameters obtained at screening as follows:
• Platelet count ≥ 125 × 103/µL
• Absolute neutrophil count ≥ 1.5 × 103/µL
• Absolute Lymphocyte levels ≥ 1000 cells/uL
• Hemoglobin ≥ 12 g/dL (male) and ≥ 11 g/dL (females)
• Prothrombin time or international normalized ratio (INR) ≤ 1.1 × upper limit of normal (ULN)

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)
• History of malignancy within the last 3 years NOTE: History of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documentation of resolution per topical treatment or complete resection as determined by a dermatologist at least 3 months prior to screening
• 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
• An underlying skin disease or disorder including, but not limited to, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria, or tattoo that would interfere with assessment of infusion sites
• History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis
• Use of any prescription or non-prescription drugs or dietary supplements that are prohibited (See Section 6.11), within 7 days prior to dosing
• Use of any immunosuppressive, immunomodulatory or cytokine therapy within 90 days prior to entry. Not Exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical steroids for mild, uncomplicated dermatitis unless it interferes with assessment of infusion site reactions; or [4] a single course of oral /parenteral prednisone or equivalent at doses <20mg/day and length of therapy <14 days with completion at least 30 days prior to enrollment.
• Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase II or higher studies of antiretroviral agents
• Regular use (daily to weekly) of known drugs of abuse within 3 months of enrollment
• Increased alcohol consumption within 6 months prior to screening, defined as an average weekly intake of >14 units for males or >7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
• Current tobacco use or current use of nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening
• Known sensitivity to any of the study interventions, or components thereof, or study drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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