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NCT01292174 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
A Phase 1 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01292174 is a Phase 1 study that has completed, run by TaiMed Biologics. The registered enrollment target is 25 participants.
The verdict
NCT01292174, a Phase 1 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group. All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.
Interventions
- BIOLOGICAL ibalizumab (biologic/MAb) for SC Injection or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01292174
The ClinicalTrials.gov registry entry for NCT01292174 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 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 (biologic/MAb) for SC Injection or placebo is the first listed.
NCT01292174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01292174 about?
NCT01292174 is a clinical study titled "Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers". The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, ...
What is the current status of trial NCT01292174?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2011-02. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01292174?
The interventions under investigation include: ibalizumab (biologic/MAb) for SC Injection or placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT01292174?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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