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NCT01872572 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD
A Phase 1 study of Healthy Volunteer, sponsored by Regado Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01872572: Completed Phase 1 study of Healthy Volunteer, sponsored by Regado Biosciences.
NCT01872572 is a Phase 1 study of Healthy Volunteer that has completed, run by Regado Biosciences. The registered enrollment target is 36 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01872572, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Regado Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC injection, with and without IV RB007 (an active control agent for RB006), in healthy young volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each (N=32); however, upon review cohort (Cohort 1-A) was necessary in order to fully define the PK profile of SC RB006. Therefore, 36 subjects were enrolled in this study. Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in \>1 dose group, and progression to the next higher dose only occurred if the prior dose level was well tolerated, as assessed by a Safety Review Committee (SRC)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Subcutaneous RB006 0.5 mg/kg
- DRUG Subcutaneous RB006 1.0 mg/kg
- DRUG Subcutaneous RB006 3.0 mg/kg
- DRUG Subcutaneous RB006 2.0 mg
Study Locations (1)
Texas
- PPD Development, LP - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-08 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT01872572 record still lists
NCT01872572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01872572 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01872572 about?
NCT01872572 is a clinical study titled "Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD". This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC injection, with and without IV RB007 (an active control agent for RB006), in healthy young volunteers. The study ori...
What is the current status of trial NCT01872572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-08. Estimated completion is 2009-12.
What conditions does trial NCT01872572 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01872572?
The interventions under investigation include: Placebo (DRUG), Subcutaneous RB006 0.5 mg/kg (DRUG), Subcutaneous RB006 1.0 mg/kg (DRUG), Subcutaneous RB006 3.0 mg/kg (DRUG), Subcutaneous RB006 2.0 mg (DRUG).
Who is sponsoring clinical trial NCT01872572?
This trial is sponsored by Regado Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01872572 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01872572's enrollment target sits among peer trials
36 71st of 112 higher than 41 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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