Clinical trials
218804
Identifier
NCT06310551
Link
https://clinicaltrials.gov/study/NCT06310551
Phase
Phase I
Status
Recruiting
Sponsor
ViiV Healthcare
More details
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
Purpose
First Time in Human Study of Long Acting VH4524184 Formulations
Interventions
Intervention 1
Oral VH4524184
Intervention 2
VH4524184 Formulation A SC
Intervention 3
Placebo Formulation A SC
Intervention 4
rHuPH20
Intervention 5
VH4524184 Formulation B SC
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-03-21
Anticipated Date of Last Follow-up
2026-06-29
Estimated Primary Completion Date
2028-01-21
Estimated Completion Date
2028-01-21
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
Age
1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Type of Participant and Characteristics
2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
3. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
4. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
Weight
5. 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/m2 (inclusive).
Sex and Contra
Health status
Negative to
: HIV, HCV, HBV, COVID 19
Considered at low risk of
: HIV
Study type
Interventional (clinical trial)
Enrollment
372
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Other/Variable/Unknown
:
"unknown
"
Studied LA-formulation(s)
Injectable
Tablet
Studied route(s) of administration
Oral
Subcutaneous
Intra-articular
Use case
Treatment
Key resources
Not provided
218547
Identifier
NCT06724640
Link
https://clinicaltrials.gov/study/NCT06724640
Phase
Phase I
Status
Recruiting
Sponsor
ViiV Healthcare
More details
The purpose of this study is to investigate safety and tolerability following single ascending subcutaneous (SC) and intramuscular (IM) doses of VH4011499 in participants without HIV. The study will also describe the pharmacokinetics following single ascending SC and IM doses of VH4011499 in participants without HIV.
Purpose
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
Interventions
Intervention 1
Drug: VH4011499 Injection (subcutaneous or intramuscular)
Intervention 2
Drug: Placebo for VH4011499 Injection
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-12-16
Anticipated Date of Last Follow-up
2025-05-12
Estimated Primary Completion Date
2028-08-16
Estimated Completion Date
2028-08-16
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.
* Male or female of non-childbearing potential.
* 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
Health status
Negative to
: HCV, HBV, HIV
Considered at low risk of
: HIV
Study type
Interventional (clinical trial)
Enrollment
168
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intramuscular
Use case
Treatment
Key resources
Not provided
218306
Identifier
NCT06012136
Link
https://clinicaltrials.gov/study/NCT06012136
Phase
Phase I
Status
Active, not recruiting
Sponsor
ViiV Healthcare
More details
The primary purpose of the study is to investigate safety and tolerability following single ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single ascending SC and IM doses of capsid inhibitors in healthy participants.
Purpose
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
Interventions
Intervention 1
Drug: VH4004280
Intervention 2
Drug: VH4011499 administered either SC, SC+ rHuPH20, or IM.
Intervention 3
Drug: Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-08-24
Anticipated Date of Last Follow-up
2025-04-17
Estimated Primary Completion Date
2026-09-02
Estimated Completion Date
2026-09-02
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:
* Participants who are overtly healthy.
* Participants who are negative on a single test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction (PCR), point of care test), performed on the day of admission (Day -1). A negative result is required prior to the administration of study intervention on Day 1.
* Male or female participants of non-childbearing potential.
* 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.
Health status
Considered at low risk of
: HIV
Negative to
: HIV, COVID 19
Study type
Interventional (clinical trial)
Enrollment
208
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intramuscular
Use case
Treatment
Key resources
