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NCT03913195 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
A Phase 3 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT03913195 is a Phase 3 study that has completed, run by TaiMed Biologics. The registered enrollment target is 43 participants.
The verdict
NCT03913195, a Phase 3 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG ibalizumab-uiyk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913195
The ClinicalTrials.gov registry entry for NCT03913195 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TaiMed Biologics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ibalizumab-uiyk is the first listed.
NCT03913195 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03913195 about?
NCT03913195 is a clinical study titled "Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection". 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 a...
What is the current status of trial NCT03913195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2019-05-30. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT03913195?
The interventions under investigation include: ibalizumab-uiyk (DRUG).
Who is sponsoring clinical trial NCT03913195?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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