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NOT YET RECRUITING
NCT07777549
PHASE2

A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)

Sponsor: Tortugas Neuroscience, Inc.

View on ClinicalTrials.gov

Summary

This study will consist of two parts. Double blind Part A will assess the safety, tolerability, and pharmacokinetics of 7 days of dosing in healthy adults, while open label Part B will evaluate the safety, tolerability, and efficacy of a 2-week treatment course in adults with tinnitus.

Official title: A Phase 2a, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRTL-913 in Healthy Adult Volunteers Under Fed Conditions (Part A), and an Open-Label Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy in Adults With Tinnitus (Part B)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09

Completion Date

2027-08

Last Updated

2026-08-20

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

TRTL-913

Participants will receive TRTL-913 capsules QD.

DRUG

Placebo

Participants will receive TRTL-913 matching placebo capsules QD.

Locations (1)

Clinical Trial Site

Auckland, New Zealand