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Developed by 
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Supported by 
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VH-5356136 (VH5356136)
Developer(s)
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ViiV Healthcare Originator
https://viivhcmedinfo.com/our-pipeline/interactive-pipeline/
United Kingdom |
Drug structure
Placeholder for VH5356136 (chemical structure not yet disclosed)
Drug information
Associated long-acting platforms
Unknown
Administration route
Route of administration is being determined in the clinical program
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
Frequency of administration
User acceptance
to be determined
Dosage
Available dose and strength
to be determined
Maximum dose
to be determined
Recommended dosing regimen
to be determined
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
Summary
Approval status
Regulatory authorities
Safety
Efficacy
Evidence Summary
Delivery device(s)
Not provided
Scale-up and manufacturing prospects
Scale-up prospects
Manufacturing information is not currently available for this compound.
Tentative equipment list for manufacturing
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
Clinical trials
300862
Identifier
NCT07822477
Link
https://clinicaltrials.gov/study/NCT07822477
Phase
Phase I
Status
Not yet recruiting
Sponsor
ViiV Healthcare
More details
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV). This study will be conducted following the availability of initial safety and PK clinical data from formulation of the parent drug VH4524184.
Purpose
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
Interventions
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2026-11-06
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2026-09-10
Estimated Primary Completion Date
2029-05-09
Estimated Completion Date
2029-05-09
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: * Participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF). * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions. * Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive). * Participants of any sex (male or female) are eligible. A female participant (female sex assigned at birth) is eligible to participate if they are a person of non-childbearing potential (PONCBP). * Capable of prov
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
160
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
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