A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
NCT06012136 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2025-09-05
Summary
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
Conditions
- HIV Infections
Interventions
- DRUG
-
VH4004280
VH4004280 will be administered.
- DRUG
-
Placebo will be administered.
- DRUG
-
VH4011499
VH4011499 will be administered.
Sponsors & Collaborators
-
ViiV Healthcare
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-08-24
- Primary Completion
- 2026-06-09
- Completion
- 2026-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
NCT01090648 ·Status: COMPLETED ·Phase: PHASE1
-
Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
NCT00000940 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
NCT00002208 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
NCT05418868 ·Status: RECRUITING ·Phase: PHASE1
-
Phase I Trial of S-1153 in Patients With HIV Infection
NCT00002214 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection
NCT00002183 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
NCT00441298 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)
NCT00920426 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
NCT05184452 ·Status: COMPLETED ·Phase: PHASE1
-
TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
NCT00111280 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART
NCT06430905 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382
NCT06032546 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
NCT02858401 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
NCT00001085 ·Status: COMPLETED ·Phase: PHASE2
-
The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
NCT00001063 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
NCT01641809 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
NCT00002424 ·Status: SUSPENDED ·Phase: PHASE2
-
PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.
NCT00908414 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs
NCT00002206 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of 141W94 and Indinavir in HIV-Infected Patients
NCT00002202 ·Status: COMPLETED ·Phase: PHASE3
-
TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
NCT00412646 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir
NCT00001133 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
NCT01656018 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
NCT00002406 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
NCT02120352 ·Status: COMPLETED ·Phase: PHASE2