Safety and PK/PD of RTA 1701 in Healthy Adults
Summary
This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. Each group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up to 3 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 10 participants who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics will be assessed in each dosing group prior to dose escalation
Timeline
- Start
- 2018-06-20
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RTA 1701 | Unknown | 10 mg | Oral |
| Subject | RTA 1701 | Unknown | 20 mg | Oral |
| Subject | RTA 1701 | Unknown | 40 mg | Oral |
| Subject | RTA 1701 | Unknown | 80 mg | Oral |
| Subject | RTA 1701 | Unknown | 160 mg | Oral |
| Subject | RTA 1701 | Unknown | 320 mg | Oral |
| Subject | RTA 1701 | Unknown | 640 mg | Oral |
Indications
No indication recorded.