Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD
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)
Timeline
- Start
- 2009-08
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Results Vavalle JP, Rusconi CP, Zelenkofske S, Wargin WA, Alexander JH, Becker RC. A phase 1 ascending dose study of a subcutaneously administered factor IXa inhibitor and its active control agent. J Thromb Haemost. 2012 Jul;10(7):1303-11. doi: 10.1111/j.1538-7836.2012.04742.x.
- Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anivamersen | Oligonucleotide (other) | 1 mg/kg | Intravenous |
| Subject | pegnivacogin | Aptamer | 0.5 mg/kg | Subcutaneous |
| Subject | pegnivacogin | Aptamer | 1 mg/kg | Subcutaneous |
| Subject | pegnivacogin | Aptamer | 2 mg/kg | Subcutaneous |
| Subject | pegnivacogin | Aptamer | 3 mg/kg | Subcutaneous |
Indications
No indication recorded.