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Safety and PK/PD of RTA 1701 in Healthy Adults

NCT03579030 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-29

No results posted yet for this study

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

DRUG

Placebo oral capsule

Placebo capsule matched to an RTA 1701 capsule

DRUG

RTA 1701 capsules

Capsule containing RTA 1701, multiple dosages

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-06-28
Completion
2019-06-28
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579030 on ClinicalTrials.gov