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RECRUITING
NCT07300189
PHASE1

A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects

Sponsor: OrsoBio, Inc

View on ClinicalTrials.gov

Summary

This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-1180 in Healthy Subjects and an Open-Label Assessment of the Relative Bioavailability of, and Effect of Food on, a Tablet Formulation of TLC-1180

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2025-10-20

Completion Date

2026-12-01

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

DRUG

TLC-1180 Oral Solution

Oral solution of TLC-1180

DRUG

TLC-1180 Tablet

Tablet formulation of TLC-1180

OTHER

Placebo Oral Solution

Placebo-to-match oral solution TLC-1180

OTHER

Placebo Tablet

Placebo-to-match tablet formulation of TLC-1180

Locations (1)

OrsoBio Research Site

Auckland, New Zealand