HIV InfectionsPhase 1NCT07525544
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
A Phase 1 study testing VH4770359 and Midazolam in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4770359 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 5 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years old
- BMI 18.5-37.0 kg/m2
- Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.
Who cannot join
- Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
- Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.
- A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
- A history of or ongoing high-risk behaviors for HIV acquisition.
- Use of prohibited medications.
- Exclusionary allergies or sensitivities.
- Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.
- Exclusionary prior or concurrent clinical study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Baltimore, Maryland, 21225
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants
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.
- Conditions
- HIV Infections
- Being tested
- VH4770359, Placebo, Midazolam
- Keywords
- First-Time-in-Human, Safety, Tolerability, Pharmacokinetics, Healthy participants, Human immunodeficiency virus (HIV), VH4770359 (GSK4770359), Oral
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4770359Drug
Participants will receive the assigned dose formulation of VH4770359 orally.
PlaceboDrug
Participants will receive placebo to match the VH4770359 dose formulation.
MidazolamDrug
Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
| Study group | Role | What they receive |
|---|---|---|
| Part A: VH4770359 SAD group | Experimental | Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD). Receives: Drug: VH4770359 |
| Part A: Placebo SAD group | Placebo comparator | Healthy participants will receive a single dose of Placebo on Day 1. Receives: Drug: Placebo |
| Part B: VH4770359 MAD group | Experimental | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD). Receives: Drug: VH4770359 |
| Part B: Placebo MAD group | Placebo comparator | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Receives: Drug: Placebo |
| Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group | Experimental | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. Receives: Drug: VH4770359; Drug: Midazolam |
| Part B: Placebo MAD DDI group | Placebo comparator | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. Receives: Drug: Placebo; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Grade 3 and Grade 4 adverse events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
Measured: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks)
Secondary outcomes (2)
Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration
AUC(0-inf) is calculated using a standard non-compartmental analysis.
Measured: At Day 1 (pre-dose, 0.5h 1h, 2h, 3h, 4h, 6h, 8h,12h), Day 2 (24h, 36h), Day 3, Day 4, Day 5, Day 6, Day 7 and during outpatient visits until the last on site study visit (up to approximately 9 weeks)
Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration
AUC(0-tau) is calculated using a standard non-compartmental analysis.
Measured: At Day 1 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) and at Day 14 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start14 May 2026
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525544
- Sponsor's protocol ID
- 300109
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07525544
- Acronym / sponsor ID
- 300109
- Conditions
- HIV Infections
- Keywords
- First-Time-in-Human, Safety, Tolerability, Pharmacokinetics, Healthy participants, Human immunodeficiency virus (HIV), VH4770359 (GSK4770359), Oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: VH4770359 SAD group | Experimental | Drug: VH4770359Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD). |
| Part A: Placebo SAD group | Placebo comparator | Drug: PlaceboHealthy participants will receive a single dose of Placebo on Day 1. |
| Part B: VH4770359 MAD group | Experimental | Drug: VH4770359Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD). |
| Part B: Placebo MAD group | Placebo comparator | Drug: PlaceboHealthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. |
| Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group | Experimental | Drug: VH4770359, Drug: MidazolamHealthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
| Part B: Placebo MAD DDI group | Placebo comparator | Drug: Placebo, Drug: MidazolamHealthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 55 years old
- BMI 18.5-37.0 kg/m2
- Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.
Key exclusion criteria (8 listed)
- Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
- Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.
- A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
- A history of or ongoing high-risk behaviors for HIV acquisition.
- Use of prohibited medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4770359Participants will receive the assigned dose formulation of VH4770359 orally. | Drug | Part A: VH4770359 SAD group, Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group, Part B: VH4770359 MAD group |
| PlaceboParticipants will receive placebo to match the VH4770359 dose formulation. | Drug | Part A: Placebo SAD group, Part B: Placebo MAD DDI group, Part B: Placebo MAD group |
| MidazolamParticipants receive 2 mg Midazolam on Days -1, Day 1 and Day 14. | Drug | Part B: Placebo MAD DDI group, Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group |
Primary outcome
Number of participants with Grade 3 and Grade 4 adverse events (AEs)
Time frame: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
2 secondary outcomes
Part A: Area under the curve from time zero extrapolated to infinity (AUC[0-inf]) of VH4770359 following single dose administration
Time frame: At Day 1 (pre-dose, 0.5h 1h, 2h, 3h, 4h, 6h, 8h,12h), Day 2 (24h, 36h), Day 3, Day 4, Day 5, Day 6, Day 7 and during outpatient visits until the last on site study visit (up to approximately 9 weeks)
Part B: AUC over a single dosing interval from time 0 to the next dose (AUC[0-tau]) of VH4770359 following multiple dose administration
Time frame: At Day 1 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h) and at Day 14 (pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH4770359 and Midazolam in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Grade 3 and Grade 4 adverse events (AEs) (time frame: From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.