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

ClinicalTrials.gov ID: NCT01872572

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID: NCT01872572
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Regado Biosciences, Inc.; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Healthy Volunteer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2009 (Type not available)
Primary completion: Dec 2009 (Actual)
Completion: Dec 2009 (Actual)
Last update posted: Jun 7, 2013

2009

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
PPD Development, LP	Austin	Texas	78744	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01872572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 7, 2013 · Synced Nov 15, 2026