Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07908134
PHASE1

Study to Establish Safety, Tolerability and Pharmacokinetics of NRL-1049 in Healthy Adult Participants Following Multiple-Dose Administration

Sponsor: Neurelis, Inc.

View on ClinicalTrials.gov

Summary

This Phase 1, dose-escalation, double-blind, multiple ascending dose (MAD) study was designed to assess the safety and tolerability of NRL-1049 compared to placebo in healthy adult participants and to determine the maximum tolerated dose (MTD) and to assess pharmacokinetics (PK) and dose proportionality. Additionally, changes in blood Rho-associated protein kinase (ROCK) activity levels will be explored.

Official title: A Randomized, Dose-Escalation, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Establish Safety, Tolerability and Pharmacokinetics of NRL-1049 in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-11

Completion Date

2027-05-26

Last Updated

2026-10-30

Healthy Volunteers

Yes

Interventions

DRUG

NRL-1049

NRL-1049 25 mg and/or 75 mg immediate-release capsules

DRUG

Placebo

Placebo-to-match NRL-1049 capsules