Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
Completed · Phase 3
Conditions studied: HIV-1-infection
In brief
This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection. An initial "Sentinel Group" of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration and decreasing administration time until undiluted IV Push over 30 seconds is achieved, while safety and pharmacokinetics are evaluated. If no safety signals are seen, the Core Group of 15 participants will be enrolled. The Core Group will receive 800mg Trogarzo via undiluted IV Push over 30 seconds while safety and pharmacokinetics are monitored. After completion of the IV Push portion of the study, a second group of 20 participants will be enrolled to evaluate the safety and pharmacokinetics of administration of 800mg via intramuscular injection.
Key facts
- Study ID
- NCT03913195
- Run by
- TaiMed Biologics Inc.
- People needed
- 43
- Starts
- 2019-05-30
- Expected to finish
- 2022-10-31
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Anthony Mills MD Inc. — Los Angeles, California, United States
- Gary Richmond MD, PA — Fort Lauderdale, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- North Texas Infectious Disease Consultants — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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