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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02029716
The ClinicalTrials.gov registry entry for NCT02029716 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (83% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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