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RTA 408 0.5%, 1%, 3%

Phase 1

Healthy | Small molecule | Other |Biogen Inc.|Last Updated: May 28, 2025

Target and mechanism

ModalitySmall molecule

Also known as RTA 408 Lotion 0.5%, 1%, 3%

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

RTA 408 0.5%, 1%, 3% · 1 trial · 1 indication

Phase 1 1
NCT02029716RTA 408 Lotion in Healthy VolunteersHealthy
COMPLETED109 Analytics
PHASE1COMPLETED
RTA 408 Lotion in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Skin changes or redness following topical application of RTA 408 lotion or lotion vehicle
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part APLACEBO_COMPARATORRTA 408 lotion 0.5%, 1%, and 3% and lotion vehicle applied to skin twice daily for 14 days
Part BEXPERIMENTALUp to 3% RTA 408 lotion applied to skin twice daily for 14 days (% concentration to be determined, based on results from Part A, \~100 cm2 surface area)
Part CEXPERIMENTAL3% RTA 408 lotion applied to skin twice daily for 28 days (\~500 cm2 surface area)

Interventions

NameTypeDescription
RTA 408 Lotion 0.5%, 1%, 3%DRUG -
Lotion vehicle/placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects must voluntarily give written informed consent and agree to comply with visit schedule including willingness to remain at the study site; 2. Subjects must be adults (male or female), ages 18 to 65, inclusive; 3. Subjects must have healthy skin on which reddening can ...

Countries:United States
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Frequently asked questions about RTA 408 0.5%, 1%, 3%

What is RTA 408 0.5%, 1%, 3%?

RTA 408 0.5%, 1%, and 3% are three lotion strengths of a small molecule drug candidate developed by Biogen Inc. (BIIB). They were studied in healthy adult volunteers rather than in patients with a disease, and the program is at the Phase 1 stage of clinical development.

Who makes RTA 408 0.5%, 1%, 3%?

Biogen Inc., which trades on Nasdaq under the ticker BIIB, is the developer of RTA 408 0.5%, 1%, and 3% lotion. The company sponsored the Phase 1 study of these lotion strengths in healthy volunteers in the United States.

What phase is RTA 408 0.5%, 1%, 3% in?

RTA 408 0.5%, 1%, and 3% lotion are in Phase 1 development. The program has one completed Phase 1 trial, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA.

What clinical trial is RTA 408 0.5%, 1%, 3% in?

RTA 408 0.5%, 1%, and 3% lotion were evaluated in the completed Phase 1 trial NCT02029716, titled RTA 408 Lotion in Healthy Volunteers. The study enrolled 109 participants in the United States, used a randomized, double-blind, placebo-controlled design, and included adults aged 18 years and older.

Is RTA 408 0.5%, 1%, 3% the same as RTA 408 Lotion 0.5%, 1%, 3%?

Yes. RTA 408 0.5%, 1%, and 3% is also known as RTA 408 Lotion 0.5%, 1%, and 3%. The two names refer to the same three lotion strengths of the investigational small molecule developed by Biogen Inc. for study in healthy volunteers.