Health TrialsbyHealthPanel

First Time in Human Study of Long Acting VH4524184 Formulations

ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorViiV Healthcare

About this trial

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).

Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.

Disqualifiers

History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

Clinically significant abnormal blood pressure as determined by the investigator.

Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

Breast cancer within the past 10 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral VH4524184

    Drug

    VH4524184 to be taken orally.

  • VH4524184 Formulation A SC

    Drug

    VH4524184 LAI Formulation A administered subcutaneously.

  • Placebo Formulation A SC

    Drug

    Placebo Formulation A administered subcutaneously.

  • rHuPH20

    Drug

    rHuPH20 administered subcutaneously.

  • VH4524184 Formulation B SC

    Drug

    VH4524184 LAI Formulation B administered subcutaneously.

  • Placebo Formulation B SC

    Drug

    Placebo Formulation B administered subcutaneously.

  • VH4524184 Formulation A IM

    Drug

    VH4524184 LAI Formulation A administered intramuscularly.

  • Placebo Formulation A IM

    Drug

    Placebo Formulation A administered intramuscularly.

  • VH4524184 Formulation B IM

    Drug

    VH4524184 LAI Formulation B administered intramuscularly.

  • Placebo Formulation B IM

    Drug

    Placebo Formulation B administered intramuscularly.

Treatment groups

372 Participants
are divided into 5 treatment groups
Group A: Formulation A SC GroupExperimental treatment 4 interventions
Group B: Formulation B SC GroupExperimental treatment 4 interventions
Group C: Formulation A IM GroupExperimental treatment 3 interventions
Group D: Formulation B IM GroupExperimental treatment 3 interventions
Group E: Multiple doses GroupExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants reporting adverse events (AEs) and related AEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Related AE = AE assessed by the investigator as related to the study drug.

Time frame
From first study dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
2

Percentage of participants with AEs by severity

Severity of AEs will be assessed using Division of AIDS Table for Grading the Severity of Adult Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redness), induration (or swelling), and pruritus. The toxicity level is graded from Grade 1 (lowest toxicity) to 4 (highest toxicity). Higher grade indicates higher toxicity.

Time frame
From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
3

Percentage of participants discontinuing the treatment due to AEs

Time frame
From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants
4

Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters

The liver panel laboratory parameters are assessed after the administration of long-acting injectable (LAI) VH4524184.

Time frame
From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Secondary outcomes

1

Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Grade 3 is defined as causing an inability to perform usual social \& functional activities with intervention or hospitalization indicated. Grade 4 is defined as an abnormality that is potentially life-threatening, causing an inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.

Time frame
From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Other outcomes

Sponsors and contacts

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

ViiV Healthcare

Lead sponsor

Source ClinicalTrials.gov
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