Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01893528 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 2
- Study locations
NCT01893528: Completed Phase 1 study of Healthy Volunteers, sponsored by Regeneron Pharmaceuticals.
NCT01893528 is a Phase 1 study of Healthy Volunteers that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 49 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893528, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.
Primary Outcome
The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.
Conditions Studied
Interventions
- OTHER placebo
- DRUG REGN2009
Study Locations (2)
Maryland
- - Baltimore
Ohio
- - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT01893528 record still lists
NCT01893528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01893528 reports a single indexed study location in Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT01893528 about?
NCT01893528 is a clinical study titled "Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers". This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.
What is the current status of trial NCT01893528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2013-06. Estimated completion is 2014-09.
What conditions does trial NCT01893528 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01893528?
The interventions under investigation include: placebo (OTHER), REGN2009 (DRUG).
Who is sponsoring clinical trial NCT01893528?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01893528 being conducted?
This trial has 2 study locations across Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01893528's enrollment target sits among peer trials
49 141st of 283 higher than 143 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
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
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric 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