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RTA 901, 10 or · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RTA 901 10 mg or 40 mg or Placebo | EXPERIMENTAL | RTA 901 capsules (10 mg or 40 mg) or placebo taken orally in a single dose. Group 1: RTA 901 10 mg or matching placebo Group 2: RTA 901 20 mg or matching placebo Group 3: RTA 901 ≤ 40 mg or matching placebo Group 4: RTA 901 ≤ 80 mg or matching placebo Group 5: RTA 901 ≤ 160 mg or matching placebo Group 6: RTA 901 ≤ 320 mg or matching placebo Group 7: RTA 901 ≤ 640 mg or matching placebo Dose selection will be based on the safety, tolerability and available pharmacokinetics observed in prior study groups. |
| RTA 901 Dose TBD or Placebo | EXPERIMENTAL | RTA 901 capsules, Dose TBD mg or placebo taken orally once daily for 14 days. Group 8: RTA 901 X mg or matching placebo Group 9: RTA 901 ≤Y mg or matching placebo Group 10: RTA 901 ≤Z mg or matching placebo The actual doses for Arm 2 will be selected based on the safety and available pharmacokinetic data obtained from Arm 1. |
| Name | Type | Description |
|---|---|---|
| RTA 901 Capsules, 10 or 40 mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or female and age is between 18 and 55 years, inclusive. * Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding. Non-childbearing potential is defined by at least one of the following criteria: 1. At least 2 years spontaneou...
RTA 901 is an investigational small molecule developed by Biogen Inc. (ticker BIIB). It has been studied in healthy adult volunteers rather than in patients with a specific disease. The program is in Phase 1 clinical development, and the compound is also referred to as RTA 901 Capsules, 10 or 40 mg.
RTA 901 has been studied in healthy adult participants, not in a patient population with a named disease. Its single clinical trial enrolled healthy volunteers to assess safety, tolerability, and pharmacokinetics. No approved therapeutic indication for RTA 901 is established, and the asset remains in early-stage clinical development.
RTA 901 is developed by Biogen Inc., which trades under the ticker BIIB. Biogen is the sponsor of the compound's clinical program. The drug is a small molecule and is also identified as RTA 901 Capsules, 10 or 40 mg in study documentation.
RTA 901 is in Phase 1 clinical development. Its only recorded trial was a Phase 1 study in healthy adults, and that trial is now completed. Because the program has not advanced beyond Phase 1, RTA 901 is investigational and has not been approved by the FDA for any indication.
RTA 901 has been evaluated in one clinical trial, NCT02666963, titled a study of the safety, tolerability, and pharmacokinetics of single and multiple doses of RTA 901 in healthy adults. That Phase 1 trial was randomized, double-blind, and controlled, enrolled 78 participants in the United States, and is completed.