Trials / Completed
CompletedNCT05204121
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
Phase Ib, Single-Center, Randomized Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Viriom · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
Detailed description
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elpida | elsulfavirine, capsules |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2019-04-02
- Completion
- 2019-04-02
- First posted
- 2022-01-24
- Last updated
- 2022-01-24
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05204121. Inclusion in this directory is not an endorsement.