NCT03579030

Safety and PK/PD of RTA 1701 in Healthy Adults

A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RTA 1701 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. Each group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up to 3 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 10 participants who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics will be assessed in each dosing group prior to dose escalation

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	Placebo capsule matched to an RTA 1701 capsule
DRUG	RTA 1701 capsules	Capsule containing RTA 1701, multiple dosages

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2018-07-06
• Last updated: 2025-05-29

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study