NCT01872572

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD

A Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RB006 Administered Subcutaneously, With and Without IV RB007, in Healthy Young Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Regado Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Subcutaneous RB006 0.5 mg/kg	Subcutaneous RB006 0.5 mg/kg
DRUG	Subcutaneous RB006 1.0 mg/kg	Subcutaneous RB006 1.0 mg/kg
DRUG	Subcutaneous RB006 3.0 mg/kg	Subcutaneous RB006 3.0 mg/kg
DRUG	Subcutaneous RB006 2.0 mg	* Arm 1: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 72 hours post-RB006 administration * Arm 2: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 24, 72, and 120 hours post-RB006 administration.
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2013-06-07
• Last updated: 2013-06-07

Locations

1 site across 1 country: United States