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VH4527079 for HIV

Phase 1
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent.
Must not have
Any previous use of HIV Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) in Arm A (Cohorts 1 through 7) or Arm B (Cohort 8 only), either oral or parenteral, is exclusionary.
Lymphoma, leukemia, or any malignancy (except for breast cancer) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 (pre-dose 1) up to week 24 follow-up period
Awards & highlights
No Placebo-Only Group

Summary

"This trial is looking at how safe and well-tolerated a new drug, VH4527079, is when given as a single dose injection under the skin or through a vein in healthy adults.

Who is the study for?
This trial is for healthy adults and individuals with HIV. Participants must be in good health or have stable HIV suppression if they are living with the virus. The study excludes anyone who has a history of significant allergic reactions, is pregnant or breastfeeding, or has any condition that could interfere with the drug's effects.
What is being tested?
The trial tests VH4527079, a human monoclonal antibody, given as a single dose by injection under the skin (SC) or into a vein (IV), and multiple doses by IV to assess its safety and how it's processed in the body.
What are the potential side effects?
Potential side effects of VH4527079 may include reactions at the injection site, general discomforts like headaches or fatigue, possible immune system responses, and other symptoms not yet known due to its newness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 18.5 and 31.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never used HIV Pre-exposure or Post-exposure prophylaxis.
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I haven't had cancer, except for skin or breast cancer, in the last 5 years.
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I am taking medication that can affect my heart's rhythm.
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I do not have any major health issues that could affect drug processing or pose a risk with the study treatment.
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My weight is over 115 kg.
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I do not have serious heart conditions like heart failure or severe arrhythmia.
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I haven't used any experimental drugs or vaccines recently.
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I have used Neonatal Fc receptor blockers before.
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I have not received any vaccines, including for COVID-19, in the last 2 weeks.
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I will not donate more than 500 mL of blood within 8 weeks.
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I am not taking any medication that is not allowed in the study, or I can switch if needed.
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I have a history of cirrhosis, with or without hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (pre-dose 1) up to week 24 follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (pre-dose 1) up to week 24 follow-up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events (AEs) of Grade 2 and above severity
Secondary study objectives
Change from baseline values for chemistry panels: Glucose (fasting), Blood Urea Nitrogen, Creatinine, Calcium, Magnesium, Potassium, Phosphate, Direct Bilirubin, Total Bilirubin and Fasting lipid panel (milligrams per deciliter)
Number of participants with any AEs and AEs by severity
Number of participants with maximum post-baseline QT interval corrected (QTc) values compared to baseline by category
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Arm B, Cohort 9Experimental Treatment1 Intervention
Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.
Group II: Arm B, Cohort 8Experimental Treatment1 Intervention
Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.
Group III: Arm A, Cohort 7Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection.
Group IV: Arm A, Cohort 6Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion.
Group V: Arm A, Cohort 5Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion.
Group VI: Arm A, Cohort 4Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion.
Group VII: Arm A, Cohort 3Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion.
Group VIII: Arm A, Cohort 2Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion.
Group IX: Arm A, Cohort 1Experimental Treatment1 Intervention
Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
375 Previous Clinical Trials
470,682 Total Patients Enrolled
~57 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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