Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00116168 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00116168: Completed Phase 1 study, sponsored by MedImmune.
NCT00116168 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116168, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
Primary Outcome
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Interventions
- BIOLOGICAL MEDI-528 0.3 mg/kg
- BIOLOGICAL MEDI-528 1 mg/kg
- BIOLOGICAL MEDI-528 3 mg/kg
- BIOLOGICAL MEDI-528 9 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2005-06 |
| Est. Completion | 2006-07 |
| Phase | Phase 1 |
What the finished NCT00116168 record still lists
NCT00116168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 4 interventions - of which MEDI-528 0.3 mg/kg is the first listed.
NCT00116168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116168 about?
NCT00116168 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528". A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
What is the current status of trial NCT00116168?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2005-06. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00116168?
The interventions under investigation include: MEDI-528 0.3 mg/kg (BIOLOGICAL), MEDI-528 1 mg/kg (BIOLOGICAL), MEDI-528 3 mg/kg (BIOLOGICAL), MEDI-528 9 mg/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00116168?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116168's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
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