AzTrials
AzTrials

HealthyPhase 1NCT02029716

RTA 408 Lotion in Healthy Volunteers

A Phase 1 study testing RTA 408 Lotion 0.5%, 1%, 3% in people with Healthy, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation. In this study, the safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be evaluated following topical application of RTA… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
RTA 408 Lotion 0.5%, 1%, 3%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
1 siteUnited States
Study dates
31 Dec 2013to 1 Apr 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must voluntarily give written informed consent and agree to comply with visit schedule including willingness to remain at the study site;
  • Subjects must be adults (male or female), ages 18 to 65, inclusive;
  • Subjects must have healthy skin on which reddening can easily be recognized (Fitzpatrick type I-IV skin);
  • The planned application site must have unbroken skin (ie, free from cuts, scratches, and abrasions), and be free of excessive hair, tattoos, or other abnormality that, in the Investigator's judgement, would interfere with the conduct of the study;
  • Subjects must have a body mass index (BMI) of ≥18 kg/m2 and ≤32 kg/m2;
  • Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding.
  • Male subjects must agree that they and any female partners will use 2 acceptable forms of contraception, 1 of which must be a condom, until 3 months after the last dose of study drug.

Who cannot join

  • Persons with Fitzpatrick skin types V or VI;
  • Presence of active inflammatory dermatoses (eg, atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections;
  • History of clinically significant drug allergies including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the Investigator;
  • Use of any alcohol or methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, and "power drinks") from 72 hours prior to the first dose of study drug until after the last protocol specified blood sample;
  • Use of any tobacco products, nicotine-containing products, or pharmacologic smoking cessation therapy during the 3 months immediately prior to the first dose of study drug, and/or not willing or able to refrain from use of any of these products for the duration of the study until after the last protocol specified blood sample;
  • History of alcohol abuse within 2 years of the Screening Visit, in the judgment of the Investigator, or average weekly alcohol consumption of >14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL);
Show all 22Show fewer
  • Positive breath test for alcohol at the Screening Visit or at Day -1;
  • History of drug abuse within 2 years of the Screening Visit, in the judgment of the Investigator;
  • Positive urine test for cotinine or drugs of abuse (ie, opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines) at the Screening Visit or at Day -1;
  • Not willing to abstain from strenuous exercise (eg, heavy lifting, weight training, calisthenics, aerobics) for at least 48 hours prior to admission to the investigational site until after the last protocol specified blood sample;
  • Use of substances known to be strong inhibitors or inducers of Cytochrome P450 (CYP450) enzymes (eg, ritonavir, ketoconazole, nefazodone, grapefruit juice) within 14 days prior to the first dose of study drug through the last study visit. Chronic exposure to enzyme inducers such as paint solvents or pesticides or other investigational drug use within 30 days prior to study drug administration;
  • Use of prescription drugs, dietary supplements, or herbal remedies (including products applied topically) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; use of non-prescription drugs or vitamins (including products applied topically) within 7 days prior to the first dose of study drug; or unwillingness to refrain from taking any such medication until after the last protocol specified blood sample;
  • Donation of whole blood >450 mL or blood products within 56 days prior to admission to the investigational site;
  • Use of any investigational drug within 30 days or 5 half-lives of the previous investigational drug prior to the first dose of study drug in this study, whichever is longer;
  • Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at the Screening Visit;
  • Acute illness accompanied by temperature ≥101○F within 5 days prior to study drug administration;
  • Presence or history of cancer within 5 years prior to the Screening Visit (other than basal cell skin cancer in a location other than the back and without active lesions and adequately treated carcinoma in situ of cervix);
  • Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic disease
  • Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. History of appendectomy and cholecystectomy is permitted;
  • Any abnormal clinical laboratory value or abnormal electrocardiogram (ECG) finding at the Screening Visit or at Day -1 that is considered clinically significant by the Investigator;
  • International Normalized Ratio (INR) >1.5 at the Screening Visit;
  • Men whose female partner is pregnant or lactating, or who plans to become pregnant during the study or within 3 months after the end of the study;

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medpace Clinical Pharmacology Unit

    Cincinnati, Ohio, 45212

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RTA 408 Lotion in Healthy Volunteers

This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation. In this study, the safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA 408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface area (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the local skin tolerability, local PD, and systemic PK of these treatments. Part B will be conducted after completion of Part A and will assess the safety, tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin surface area (~100 cm2). Part C will be conducted after completion of Part B and will assess the safety, tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for 28 days to a larger skin surface area (~500 cm2). The maximum tolerated drug concentration in Part A will be used in Part B and Part C.

Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers in Part A and 10 volunteers each, in Parts B and C.

Conditions
Healthy
Being tested
RTA 408 Lotion 0.5%, 1%, 3%, Lotion vehicle/placebo
Keywords
RTA 408, RTA 408 Lotion, Oxidative stress, Inflammation, Volunteers
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTA 408 Lotion 0.5%, 1%, 3%Drug

  • Lotion vehicle/placeboDrug

Study groups in NCT02029716
Study groupRoleWhat they receive
Part APlacebo comparatorRTA 408 lotion 0.5%, 1%, and 3% and lotion vehicle applied to skin twice daily for 14 days
Receives: Drug: RTA 408 Lotion 0.5%, 1%, 3%; Drug: Lotion vehicle/placebo
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)
Receives: Drug: RTA 408 Lotion 0.5%, 1%, 3%
Part CExperimental3% RTA 408 lotion applied to skin twice daily for 28 days (~500 cm2 surface area)
Receives: Drug: RTA 408 Lotion 0.5%, 1%, 3%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin changes or redness following topical application of RTA 408 lotion or lotion vehicle

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2014 (estimated)
  2. Study start31 Dec 2013
  3. Primary completion1 Apr 2014
  4. Study completion1 Apr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02029716
Sponsor's protocol ID
RTA 408-C-1305
Status last verified
May 2025
First submitted
30 Dec 2013
Last updated
28 May 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • Reisman SA, Goldsberry AR, Lee CY, O'Grady ML, Proksch JW, Ward KW, Meyer CJ. Topical application of RTA 408 lotion activates Nrf2 in human skin and is well-tolerated by healthy human volunteers. BMC Dermatol. 2015 Jul 14;15:10. doi: 10.1186/s12895-015-0029-7.

    PubMed 26170027

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RTA 408 Lotion 0.5%, 1%, 3% in people with Healthy, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin changes or redness following topical application of RTA 408 lotion or lotion vehicle (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02029716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in