Actively Recruiting
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 Adults and Open-label Assessments in Participants With Ulcerative Colitis
Led by TrueLab Biopharmaceutical Co., Ltd · Updated on 2026-05-15
48
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, tolerability, pharmacokinetics (how the drug moves through the body), pharmacodynamics (how the drug affects the body), and immune response of TL-003, an investigational drug given intravenously, in healthy adults. This Phase 1 randomized, double-blind, placebo-controlled study includes single ascending dose (SAD) and multiple ascending dose (MAD) groups to assess TL-003 in healthy adult participants, as well as open-label assessments in participants with ulcerative colitis. The study involves six groups of 8 participants each, randomized in a 3:1 ratio to receive either TL-003 or a placebo intravenously. Four groups receive single ascending doses of TL-003 or placebo at increasing dose levels, while two groups receive multiple ascending doses or placebo. The intervention is administered under double-blind conditions to evaluate dose-related safety and drug behavior in the body across different dosing schedules. Participants will undergo safety and laboratory assessments including vital signs, electrocardiograms, and clinical laboratory tests before and after dosing, with follow-up lasting up to 169 days. Researchers will monitor for treatment-emergent adverse events and measure detailed pharmacokinetic parameters such as maximum concentration, time to maximum concentration, half-life, and drug clearance. The study includes careful monitoring of immune response and tolerability throughout its duration, with a total participation period extending several months to capture both immediate and longer-term data.
CONDITIONS
Brief Title
A Safety and Pharmacokinetics Study of TL-003 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 ≥ 50 kg for males and ≥ 45 kg for females
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to use effective contraception plus condoms consistently from 30 days prior to Day 1 until the end of study visit
- Male participants must agree to use condoms if sexually active with females of childbearing potential from Day 1 until the end of study visit, or be surgically sterilized at least 6 months prior to screening
- No clinically significant findings by medical history, physical examination, vital signs, ECG, and laboratory tests within 28 days prior to treatment
You will not qualify if you...
- History or presence of clinically significant organ system disease or immunological abnormalities
- Any abnormality or illness affecting drug absorption, distribution, metabolism, or elimination
- Screening laboratory values outside normal range judged clinically significant, including low eGFR, elevated liver enzymes, abnormal bilirubin, or low white blood cell count
- Blood pressure outside 90-140 mmHg systolic or 50-90 mmHg diastolic, or heart rate outside 40-100 beats/min
- Clinically significant ECG abnormalities or prolonged QTcF interval
- Major surgery or major trauma within 3 months prior to Day 1 without full recovery
- History of malignancy except treated nonmelanoma skin cancer
- Active or latent tuberculosis, positive tests for HIV, hepatitis B or C
- Recent or serious infections requiring treatment
- Significant allergies to medications
- Recent use of prescription or over-the-counter medications except specified exceptions
- Smoking more than 5 cigarettes per day or nicotine equivalent in last 3 months
- Excessive alcohol use or positive alcohol breath test
- History of drug or alcohol addiction in last 2 years or positive drug test
- Recent live vaccination or planned vaccinations within specified windows
- Pregnant or lactating women
- Inability to commit to full participation
- Other conditions increasing risk or affecting study evaluation
- Known exposure to anti-TL1A or anti-IL23 therapies
- Recent blood or plasma donation or planned donation during study
- Participation in other investigational studies within 30 days or 5 half-lives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 169 days
Participants receive a single or multiple ascending dose of TL-003 or placebo administered intravenously as part of the study treatment.
1 to 2 visits depending on cohort assignment
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
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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