NCT07300189

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: OrsoBio, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-1180 in healthy subjects. The exploratory objective is to evaluate the PD of TLC-1180 in healthy subjects. This study is comprised of four parts: Part A (single-ascending dose), Part B (multiple-ascending dose), optional Part C (adaptive single- and/or multiple-ascending dose), and Part D (relative bioavailability of a tablet formulation of TLC-1180). Up to 72, 100, 100, and 8 healthy subjects will be recruited in Parts A, B, C, and D, respectively. The effect of food on TLC-1180 PK will also be evaluated in this study.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2025-12-23
• Last updated: 2026-04-14

Locations

1 site across 1 country: New Zealand