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RTA 901, 10 or

Phase 1

Healthy | Small molecule | Other |Biogen Inc.|Last Updated: May 29, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

RTA 901, 10 or · 1 trial · 1 indication

Phase 1 1
NCT02666963A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy AdultsHealthy
COMPLETED78 Analytics
PHASE1COMPLETED
A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
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Study Endpoints

Primary Endpoints

Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical laboratory tests, 12-lead ECGs, and vital signs
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RTA 901 10 mg or 40 mg or PlaceboEXPERIMENTALRTA 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 PlaceboEXPERIMENTALRTA 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.

Interventions

NameTypeDescription
RTA 901 Capsules, 10 or 40 mgDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about RTA 901, 10 or

What is RTA 901?

RTA 901 is an investigational small molecule being developed by Biogen Inc. (BIIB). It is currently in Phase 1 clinical development. The drug has been studied in healthy adults to evaluate its safety, tolerability, and pharmacokinetics.

What is RTA 901 used for?

RTA 901 is being studied for use in healthy adults. The completed Phase 1 trial focused on assessing the safety, tolerability, and pharmacokinetics of single and multiple doses of the drug. No specific disease indication has been reported for RTA 901.

Who makes RTA 901?

RTA 901 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical research on this investigational small molecule.

What phase is RTA 901 in?

RTA 901 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.

What clinical trials is RTA 901 in?

RTA 901 has been studied in one completed Phase 1 clinical trial, identified as NCT02666963. This trial evaluated the safety, tolerability, and pharmacokinetics of single and multiple doses of RTA 901 in healthy adults in the United States.

Is RTA 901 the same as any other drug?

No alternative names for RTA 901 have been reported. The drug is known only as RTA 901 in clinical development. It is a small molecule being investigated by Biogen Inc. for potential therapeutic use.