Health Trials

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

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

Treatments tested in this trial

  • Oral VH4524184
  • VH4524184 Formulation A SC
  • Placebo Formulation A SC
  • rHuPH20
  • VH4524184 Formulation B SC
  • Placebo Formulation B SC
  • VH4524184 Formulation A IM
  • Placebo Formulation A IM
  • VH4524184 Formulation B IM
  • Placebo Formulation B IM

Treatment groups

372 Participants
are divided into 5 treatment groups

Sponsors and collaborators

ViiV Healthcare

Lead sponsor

Source ClinicalTrials.gov