NCT05483998

A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-2716 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• 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, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.

Detailed description

This study is a randomized, placebo-controlled, sponsor-unblinded, and comprised of three parts: Part A (single-ascending dose), Part B (multiple-ascending dose), and Part C (adaptive single- and/or multiple-ascending dose).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TLC-2716	TLC-2716
OTHER	Placebo	Placebo to match

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-04-13
• Completion: 2023-06-18
• First posted: 2022-08-02
• Last updated: 2024-05-20

Locations

1 site across 1 country: New Zealand