NCT03706911

Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects

An Open-label Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI After Single and Multiple Ascending Dose Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Viriom · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers

Detailed description

Primary Objective: To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers. Secondary Objectives: To evaluate pharmacokinetic parameters of VM-1500A after its single and multiple intramuscular ascending dose administration to healthy volunteers. To evaluate safety and tolerability of ELPIDA®, administered in the run-in period

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	VM-1500A-LAI	VM-1500A (parent drug of elsulfavirine) IM injection dosage form

Timeline

• Start date: 2019-01-21
• Primary completion: 2020-03-27
• Completion: 2020-05-18
• First posted: 2018-10-16
• Last updated: 2021-12-15

Locations

1 site across 1 country: Russia