MedTrace Logo

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

NCT03730311 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-05-20

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Elpida

elsulfavirine, capsules

DRUG

placebo

placebo

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Somruedee Chatsiricharoenkul, Assoc. Prof., MD · Siriraj Hospital Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730311 on ClinicalTrials.gov