Healthy Volunteer Clinical Trial
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
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)
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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