Health TrialsbyHealthPanel

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

ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Daily steroid or long-acting beta-agonist prevention

Hospitalization in the last two years

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Cohort 1Other 1 intervention
Group B: Cohort 2Other 1 intervention
Group C: Cohort 3Other 1 intervention
Group D: Cohort 4Other 1 intervention
Group E: Cohort 5Other 1 intervention
Group F: Cohort 6Other 1 intervention
Group G: Cohort 7Other 1 intervention
Group H: Cohort 8Other 1 intervention
Group I: Cohort 9Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From first dose of study treatment through Day 28/end of study
2

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.

Time frame
From first dose of study treatment through Day 28/end of study
3

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.

Time frame
From first dose of study treatment through Day 28/end of study
4

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.

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

Secondary outcomes

1

Mean Area Under the Concentration-time Curve (AUC)

Total body exposure to IAP086

Time frame
Pre-infusion through 24-hours post-end of infusion
2

Mean Maximum Concentration (Cmax) of IAP086

The highest concentration of IAP086

Time frame
Pre-infusion through 24-hours post-end of infusion
3

Mean Time to Maximal Concentration (Tmax) of IAP086

The amount of time required to reach maximum concentration of IAP086

Time frame
Pre-infusion through 24-hours post-end of infusion
4

Mean Concentration at 24 hours post-IAP086 (C24)

The minimum concentration of IAP086

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Source ClinicalTrials.gov
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