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

NCT01872572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-06-07

No results posted yet for this 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

  • Healthy Volunteer

Interventions

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

Sponsors & Collaborators

  • Regado Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew M Medlock, MD · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01872572 on ClinicalTrials.gov