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A Safety and Pharmacokinetics Study of TL-003 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis

NCT07526519 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-15

No results posted yet for this study

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

DRUG

TL-003

Intravenously administered

DRUG

Placebo

Intravenously administered

Sponsors & Collaborators

  • SAPRO Consulting Pty Ltd

    collaborator UNKNOWN

  • TrueLab Biopharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526519 on ClinicalTrials.gov