Clinical Trials Directory

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UnknownNCT03730311

Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers

Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Viriom · Industry
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

A randomized, placebo-controlled, once weekly dose for four weeks, double blind study in Healthy HIV-Uninfected Volunteers. Each of 3 consequent groups (120 mg, 200 mg and 280mg) enrolls 6 active and 2 placebo subjects.

Detailed description

The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.

Conditions

Interventions

TypeNameDescription
DRUGElpidaelsulfavirine, capsules
DRUGplaceboplacebo

Timeline

Start date
2019-05-01
Primary completion
2019-11-01
Completion
2019-12-01
First posted
2018-11-05
Last updated
2019-05-20

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT03730311. Inclusion in this directory is not an endorsement.