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RTA 1701

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 Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

RTA 1701 · 1 trial · 1 indication

Phase 1 1
NCT03579030Safety and PK/PD of RTA 1701 in Healthy AdultsHealthy
COMPLETED90 Analytics
PHASE1COMPLETED
Safety and PK/PD of RTA 1701 in Healthy Adults
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
3 weeks

Safety will be assessed based on the number of treatment-emergent adverse events

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Dose of RTA 1701 or PlaceboEXPERIMENTALRTA 1701 capsules or placebo taken orally in a single dose. Group 1: RTA 1701 10 mg or matching placebo Group 2: RTA 1701 ≤ 20 mg or matching placebo Group 3: RTA 1701 ≤ 40 mg or matching placebo Group 4: RTA 1701 ≤ 80 mg or matching placebo Group 5: RTA 1701 ≤ 160 mg or matching placebo Group 6: RTA 1701 ≤ 320 mg or matching placebo Group 7: RTA 1701 ≤ 640 mg or matching placebo
Multiple Dose of RTA 1701 or PlaceboEXPERIMENTALRTA 1701 capsules, Dose TBD mg or placebo taken orally once daily for 14 weeks. Group 8: RTA 1701 ≤40 mg or matching placebo Group 9: RTA 1701 ≤160 mg or matching placebo Group 10: RTA 1701 ≤640 mg or matching placebo

Interventions

NameTypeDescription
Placebo oral capsuleDRUGPlacebo capsule matched to an RTA 1701 capsule
RTA 1701 capsulesDRUGCapsule containing RTA 1701, multiple dosages
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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; * Female participants of childbearing potential must: * Not be pregnant, or lactating, or planning a pregnancy, and * Be willing to use contraception (hormonal contraceptives, diaphragm, or intrauterine contraceptio...

Countries:Australia
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Frequently asked questions about RTA 1701

What is RTA 1701?

RTA 1701 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 volunteers to evaluate its safety and pharmacokinetic and pharmacodynamic properties.

What is RTA 1701 used for?

RTA 1701 is being studied for use in healthy adults. It is an investigational small molecule in Phase 1 development. The completed clinical trial focused on safety and pharmacokinetic and pharmacodynamic parameters in healthy volunteers, not on treating a specific disease.

Who makes RTA 1701?

RTA 1701 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen is the sponsor of the clinical trial for this investigational small molecule.

What phase is RTA 1701 in?

RTA 1701 is in Phase 1 clinical development. It is an investigational small molecule and is not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is RTA 1701 in?

RTA 1701 has one completed Phase 1 clinical trial, NCT03579030, titled "Safety and PK/PD of RTA 1701 in Healthy Adults." The trial enrolled 90 healthy participants in Australia, was randomized, double-blind, and controlled, and included adults aged 18 years and older.