Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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)