Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects
NCT03706911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2021-12-15
Summary
To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple intramuscular ascending dose to healthy volunteers
Conditions
Interventions
- DRUG
-
VM-1500A-LAI
VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Sponsors & Collaborators
-
Viriom
lead INDUSTRY
Principal Investigators
-
Elena Smolyarchuk, PhD · I.M. Sechenov First Moscow State Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-21
- Primary Completion
- 2020-03-27
- Completion
- 2020-05-18
Countries
- Russia
Study Locations
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