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VH-079 (VH4527079)

Developer(s)

ViiV Healthcare

Originator
https://viivhcmedinfo.com/our-pipeline/interactive-pipeline/

Drug structure

Placeholder for VH-079

Placeholder for VH-079

Drug information

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Administration route

Subcutaneous, Intravenous

Therapeutic area(s)

HIV

Use case(s)

Treatment

Use of drug

Ease of administration

Administered by a nurse
To be determined

Frequency of administration

Other/Variable/Unknown : To be determined ; anticipated 6 monthly to be confirmed in clinical trials

User acceptance

Not provided

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

VH4527079; VH079

Brand name

Not applicable (investigational; no brand name assigned)

Compound type

Biotherapeutic

Drug class/category

Human monoclonal antibody for HIV

Summary

VH4527079 (VH-079) is an investigational human monoclonal antibody in development by ViiV Healthcare for HIV. It is in first-in-human evaluation under NCT06652958, a phase 1 open-label study of single subcutaneous or intravenous dosing in healthy adults, and multiple intravenous dosing in healthy adults and in people with HIV. It might be a bispecific antibody with an anticipated target of every-6-month dosing interval by subcutaneous or intravenous administration. The targeted epitopes are not yet disclosed, nor the half-life extension strategy.

Approval status

Not approved in any jurisdiction as of September 2026. Investigational; phase 1 (first-in-human), active and not recruiting.

Regulatory authorities

No marketing authorisation application identified. Developed under a US FDA IND held by ViiV Healthcare.

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

Delivery device(s)

Not provided

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

221877

Identifier

NCT06652958

Link

https://clinicaltrials.gov/study/NCT06652958

Phase

Phase I

Status

Active, not recruiting

Sponsor

ViiV Healthcare

More details

This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).

Purpose

A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV

Interventions

Intervention 1

VH4527079

Countries

United States of America

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-10-02

Anticipated Date of Last Follow-up
2026-06-29

Estimated Primary Completion Date
2026-09-09

Estimated Completion Date
2026-09-09

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

Genders

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent. * Participants who are overtly healthy based on a 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. * For Cohort 9 (PWH in Arm B), well controlled HIV on first-line INSTI-based oral antiretroviral therapy without history of virologic failure (will be continued during study). * Body weight more than or equal to (\>=)50.0 kg for men and \>=45.0 kg for women and Body Mass Index (BMI) within the range 18.5 to 31.0 kg/m\^2. * Contraceptive use by men or women should be consist

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

102

Allocation

Not provided

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Every 6 months
Other/Variable/Unknown : "unclear dosing frequency "

Studied LA-formulation(s)

Injectable

Studied route(s) of administration

Intravenous
Subcutaneous

Use case

Treatment

Key resources

Not provided

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

Additional information

Not provided