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Non-nucleoside reverse transcriptase inhibitor

Cohort 1 for HIV

Phase 1
Waitlist Available
Led By Brett Smith, MD, PhD
Research Sponsored by Viriom
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to comprehend the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire study;
Willingness to give written consent to participate after reading the consent form, and after having the opportunity to discuss the study with the investigator or his/her delegate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days
Awards & highlights

Study Summary

To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of AEs and SAEs.
Secondary outcome measures
VM-1500A plasma concentration

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Elsulfavirine 80 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled
Group II: Cohort 2Experimental Treatment1 Intervention
Elsulfavirine 40 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled
Group III: Cohort 1Experimental Treatment1 Intervention
Elsulfavirine 20 mg. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elsulfavirine
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViriomLead Sponsor
16 Previous Clinical Trials
3,881 Total Patients Enrolled
Brett Smith, MD, PhDPrincipal InvestigatorAltasciences Clinical Los Angeles, Inc.

Frequently Asked Questions

~8 spots leftby Mar 2025