Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by TaiMed Biologics.
NCT01292174 is a Phase 1 study that has completed, run by TaiMed Biologics. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and Tolerability Measures Include: * Physical examinations * Vital sign measurements * Anti-ibalizumab antibody levels (immunogenicity of ibalizumab) * Clinical laboratory parameters (hematology, serum chemistry and urinalysis) * Urine or serum pregnancy tests * Adverse events * Serious Adverse Events
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 |
What the finished NCT01292174 record still lists
NCT01292174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01292174's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia