NCT07526519

A Safety and Pharmacokinetics Study of TL-001 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis

A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TL-003 in Healthy Adult Participants and Open-label Assessments in Participants With Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: TrueLab Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate safety, tolerability, pharmacokinetics (PK)), pharmacodynamics (PD) and immunogenicity of single and multiple ascending dose of TL-003 in healthy adult participants.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	TL-003	Intravenously administered
DRUG	Placebo	Intravenously administered

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Australia