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Developed by 
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Supported by 
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VH4770359 (VH-359)
Developer(s)
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ViiV Healthcare Originator
https://viivhealthcare.com/
United Kingdom ViiV Healthcare is a pharmaceutical company that specializes in the development of therapies for HIV infection. The company is headquartered in Brentford in the United Kingdom and was initially formed in November 2009 as a part of a joint venture between GlaxoSmithKline and Pfizer. Shionogi joined in October 2012 |
Drug structure
Placeholder for structure of VH-359 (VH-4770359)
Drug information
Associated long-acting platforms
Oral solid form
Administration route
Oral
Therapeutic area(s)
Use case(s)
Not provided
Use of drug
Ease of administration
Frequency of administration
User acceptance
Dosage
Available dose and strength
Not provided
Maximum dose
Not provided
Recommended dosing regimen
Not provided
Additional comments
Not provided
Dosage link(s)
Not provided
Drug information
Drug's link(s)
Not provided
Generic name
Brand name
Compound type
Drug class/category
Lifecycle status
Summary
Approval status
Regulatory authorities
Safety
Efficacy
Evidence Summary
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Not provided
Tentative equipment list for manufacturing
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
Clinical trials
300109
Identifier
NCT07525544
Link
https://clinicaltrials.gov/study/NCT07525544
Phase
Phase I
Status
Recruiting
Sponsor
ViiV Healthcare
More details
VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.
Purpose
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
Interventions
Intervention 1
Intervention 2
Intervention 3
Countries
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2026-05-14
Anticipated Date of Last Follow-up
2026-07-10
Estimated Primary Completion Date
2027-05-05
Estimated Completion Date
2027-05-05
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
- Adults
Genders
- All
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied populations
Inclusion Criteria: 1. 18 to 55 years old 2. BMI 18.5-37.0 kg/m2 3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential. Exclusion Criteria: 1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct. 2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy. 3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV). 4. A history of or ongoing high-risk behaviors for HIV acquisition. 5. Use of prohibited
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
214
Allocation
Randomized
Intervention model
Sequential assignment
Intervention model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Studied route(s) of administration
Use case
Treatment
Key resources
Excipients
Proprietary excipients used
Not provided
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
Not provided
Patent info
There are either no relevant patents or these were not yet submitted to LAPaL
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
There are no additional links