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NCT02029716 · ClinicalTrials.gov registry record · Phase 1
RTA 408 Lotion in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT02029716: Completed Phase 1 study of Healthy, sponsored by Biogen.
NCT02029716 is a Phase 1 study of Healthy that has completed, run by Biogen. The registered enrollment target is 109 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02029716, a Phase 1 study of Healthy, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study 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 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 Studied
Interventions
- DRUG RTA 408 Lotion 0.5%, 1%, 3%
- DRUG Lotion vehicle/placebo
Study Locations (1)
Ohio
- Medpace Clinical Pharmacology Unit - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2013-12-31 |
| Est. Completion | 2014-04-01 |
| Phase | Phase 1 |
What the finished NCT02029716 record still lists
NCT02029716 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which RTA 408 Lotion 0.5%, 1%, 3% is the first listed.
NCT02029716 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02029716 about?
NCT02029716 is a clinical study titled "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...
What is the current status of trial NCT02029716?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2013-12-31. Estimated completion is 2014-04-01.
What conditions does trial NCT02029716 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02029716?
The interventions under investigation include: RTA 408 Lotion 0.5%, 1%, 3% (DRUG), Lotion vehicle/placebo (DRUG).
Who is sponsoring clinical trial NCT02029716?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02029716 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02029716's enrollment target sits among peer trials
109 203rd of 1090 higher than 888 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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