Trials / Active Not Recruiting
Active Not RecruitingNCT06970223
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
Phase 1, Open-Label, Randomised Crossover Study Assessing the Tolerability and Acceptability of Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabotegravir long-acting | A single CAB LA injection administered intramuscularly. |
| DRUG | Lenacapavir long-acting | Two LEN LA injections administered subcutaneously. |
Timeline
- Start date
- 2025-04-22
- Primary completion
- 2025-07-15
- Completion
- 2026-07-10
- First posted
- 2025-05-14
- Last updated
- 2025-11-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06970223. Inclusion in this directory is not an endorsement.