A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults
Public ClinicalTrials.gov record NCT02666963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects. This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD) and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4 will be assessed in each group prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3 groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose escalation.
Study identification
- NCT ID
- NCT02666963
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2016
- Primary completion
- Jul 22, 2017
- Completion
- Jul 22, 2017
- Last update posted
- May 28, 2025
2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02666963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2025 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02666963 live on ClinicalTrials.gov.