A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2028-08-16

Brief Summary

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The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM) in participants without HIV.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single ascending dose (SAD) Group

Participants in this group will be randomized to receive a single dose of either VH4011499 low dose or VH4011499 high dose or placebo.

Group Type EXPERIMENTAL

VH4011499 low dose Injection

Intervention Type DRUG

VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.

VH4011499 high dose Injection

Intervention Type DRUG

VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.

Placebo

Intervention Type DRUG

Placebo Injection will be administered either subcutaneously or intramuscularly.

Multiple ascending doses (MAD) Group

Participants in this group will be randomized to receive two doses of either VH4011499 low dose or VH4011499 high dose or placebo.

Group Type EXPERIMENTAL

VH4011499 low dose Injection

Intervention Type DRUG

VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.

VH4011499 high dose Injection

Intervention Type DRUG

VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.

Placebo

Intervention Type DRUG

Placebo Injection will be administered either subcutaneously or intramuscularly.

Interventions

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VH4011499 low dose Injection

VH4011499 low dose Injection will be administered subcutaneously and/or intramuscularly.

Intervention Type DRUG

VH4011499 high dose Injection

VH4011499 high dose Injection will be administered subcutaneously and/or intramuscularly.

Intervention Type DRUG

Placebo

Placebo Injection will be administered either subcutaneously or intramuscularly.

Intervention Type DRUG

Eligibility Criteria

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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.
* Participants may be male or female. Participants assigned female at birth are eligible to participate if they are not pregnant, not planning to become pregnant during the study, not breast/chest feeding or planning to breast/chest feed during the study and one of the following applies:

* Is a Participant of Nonchildbearing potential (PONCBP)
* Is a Participant of Childbearing potential (POCBP) and using a highly effective method of contraception through 78 weeks after the last dose of parenteral VH4011499 or through the end of the study. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a POCBP with an early pregnancy.
* Capable of giving signed informed consent.

Exclusion Criteria

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
* Abnormal blood pressure.
* Lymphoma, leukemia, or any malignancy 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.
* Breast cancer within the past 10 years.
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
* History of clinically relevant hepatitis within last 6 months.
* Patients with chronic hepatitis B infection.
* History of sensitivity to any of the study interventions, a history of drug allergy or other allergy that contraindicates their participation.
* The participant has an underlying skin disease or disorder that would interfere with assessment of injection sites.
* Participants considered to have insufficient musculature to allow safe VH4011499 intramuscular administration will be excluded.
* History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition.
* Any preexisting physical or mental condition which may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
* Past or intended use over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing
* Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
* Current enrollment or recent past participation in another investigational study.
* Positive HIV antibody/antigen test.
* ALT more than or equal to (\>=)1.5x upper limit of normal (ULN), Total bilirubin \>=1.5x ULN (isolated total bilirubin more than (\>)1.5xULN), and/or estimated creatinine clearance (eGFR) of less than (\<)60 millilitre per minute (mL/min)/1.73 square meter (m\^2).
* Regular use of tobacco or nicotine-containing products, regular alcohol consumption and/or use of known drugs of abuse.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec.
* Evidence of previous myocardial infarction, any conduction abnormality, any significant arrhythmia, non-sustained or sustained ventricular tachycardia, and/or sinus pauses (\>3 seconds).
* The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants or fillers which may interfere with interpretation of ISRs or administration of study product.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes