Actively Recruiting
A Safety and Pharmacokinetics Study of TL-001 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis
Led by TrueLab Biopharmaceutical Co., Ltd · Updated on 2026-04-13
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
TrueLab Biopharmaceutical Co., Ltd
Lead Sponsor
S
SAPRO Consulting Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Pharmacokinetics Study of TL-001 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 55 years of age.
- Body mass index (BMI) between 18.0 to 32.0 kg/m2 (inclusive).
- Body weight at least 50 kg for males and 45 kg for females.
- Able to participate and comply with all study procedures and restrictions.
- Willing to provide written informed consent.
- Female participants who are not pregnant or breastfeeding and meet at least one of the following: not of childbearing potential; or of childbearing potential and agree to use a highly effective contraception method plus condom use consistently from 30 days prior to Day 1 until the end of study visit; or agree not to donate ova from Day 1 until end of study visit.
- Male participants must use condoms if sexually active with females of childbearing potential from Day 1 until the end of study visit, or must be surgically sterilized at least 6 months prior to screening and agree not to donate sperm from Day 1 until end of study visit.
- No clinically significant findings by medical history, physical examination, vital signs, ECG, and lab tests obtained within 28 days prior to study treatment.
You will not qualify if you...
- History or presence of any clinically significant organ system disease that could interfere with study objectives or participant safety.
- History of immunological abnormality including primary or secondary immune suppression.
- Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism, or elimination of study treatment.
- Screening lab results outside normal reference ranges judged clinically significant, including eGFR < 80 mL/min/1.73m2, ALT or AST > 1.5 times upper limit of normal, total bilirubin > 1.5 times upper limit of normal (with exceptions), white blood cell count < 3,000 cells/mm3.
- Blood pressure outside 90-140 mmHg systolic or 50-90 mmHg diastolic; heart rate outside 40-100 beats/min.
- ECG abnormalities considered clinically significant or QTcF interval above 450 msec for men or 470 msec for women.
- Major surgery or traumatic injury within 3 months prior to Day 1 without full recovery.
- History or current malignancy except fully treated nonmelanoma skin cancers.
- History or active tuberculosis infection or latent TB infection.
- Positive tests for HIV, hepatitis B surface antigen, or hepatitis C antibodies.
- Recent or serious infections requiring treatment or hospitalization.
- Significant allergy to any medication.
- Use of prescription medications within 14 days prior to Day 1 or over-the-counter medications within 7 days prior, except contraception, paracetamol, and standard multivitamins.
- Smoking more than 5 cigarettes per day in the 3 months prior to Day 1 or unwilling to avoid nicotine during confinement.
- Excessive alcohol use or positive alcohol test at screening.
- History of drug or alcohol dependence or positive drug tests.
- Receipt of live vaccine within 2 months prior to baseline or inactivated vaccine within 14 days prior or planned within 14 days post treatment.
- Pregnant or lactating women.
- Inability to commit to full participation.
- Any other conditions judged by Investigator to increase risk or interfere with study.
- Known exposure to anti-TL1A or anti-IL23 therapies.
- Recent blood or plasma donation or significant blood loss within 30 days prior to screening or planned during study.
- Participation in other investigational studies within 30 days or 5 half-lives prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linear Early Phase Ltd
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
P
Peter Schrader, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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