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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Safety and Pharmacokinetics Study of TL-003 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

A Safety and Pharmacokinetics Study of TL-003 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis (NCT07526519) is a Phase 1 interventional studying Healthy Volunteer, sponsored by TrueLab Biopharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy Volunteer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate in the study. - Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: 1. Not of childbearing potential 2. Of childbearing potential and agrees to use a highly effective method of contraception plus condom use consistently from 30 days prior to Day 1 until the EOS visit. 3. Should not donate ova from Day 1 until the EOS Visit. - Male participants must use condom if sexually active with females of childbearing potential from Day 1 until the EOS visit. The female partner of a male participant who does not meet the definition of postmenopausal or permanently surgically sterile is considered of childbearing potential and is required to use a highly effective method of contraception consistently from 30 days prior to Day 1 until the EOS visit of the male participant. Male participants who are surgically sterilized, performed at least 6 months prior to screening, may be enrolled. Male participants must also agree not to donate sperm from Day 1 until the EOS visit. - No clinically significant findings as determined by medical history, and by results of physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests obtained within 28 days prior to study treatment administration. Who Should NOT Join This Trial: - History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the participants. - History of immunological abnormality (i.e., primary or secondary immune suppression) that could interfere with the objectives of the study or the safety of the participants. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 to participate in the study. * Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: 1. Not of childbearing potential 2. Of childbearing potential and agrees to use a highly effective method of contraception plus condom use consistently from 30 days prior to Day 1 until the EOS visit. 3. Should not donate ova from Day 1 until the EOS Visit. * Male participants must use condom if sexually active with females of childbearing potential from Day 1 until the EOS visit. The female partner of a male participant who does not meet the definition of postmenopausal or permanently surgically sterile is considered of childbearing potential and is required to use a highly effective method of contraception consistently from 30 days prior to Day 1 until the EOS visit of the male participant. Male participants who are surgically sterilized, performed at least 6 months prior to screening, may be enrolled. Male participants must also agree not to donate sperm from Day 1 until the EOS visit. * No clinically significant findings as determined by medical history, and by results of physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests obtained within 28 days prior to study treatment administration. Exclusion Criteria: * History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the participants. * History of immunological abnormality (i.e., primary or secondary immune suppression) that could interfere with the objectives of the study or the safety of the participants. * Presence or history of any abnormality or illness, which in the opinion of the Investigator (or designee) may affect absorption, distribution, metabolism or elimination of the study treatment. * Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator (or designee) to be clinically significant, including but not limited to: 1. Participants with estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73m2 as determined by the CKD-EPI 2021 formula, at the Screening or Baseline visits. 2. Alanine amino transferase (ALT) or aspartate amino transferase (AST) \>1.5 times upper limit of normal (ULN), which remains similar upon repeat, at the Screening or Baseline visits. 3. Total bilirubin \> 1.5 × ULN at the Screening or Baseline visits. Total bilirubin \> 1.5 × ULN is acceptable if, direct bilirubin \< 40%, normal AST/ALT/ alkaline phosphatase (ALP), and no evidence of hemolysis, according to Investigator (or designee) discretion. 4. White blood cell count \< 3,000 cells/mm3 (\< 3.0×10 9/L) or any abnormal evaluations judged clinically significant by the Investigator (or designee) at the Screening or Baseline visits. Note: If the test results meet the above criteria, a repeat test may be performed to determine eligibility. * Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic, heart rate 40-100 beats/min. * 12-lead ECG with any abnormality judged by the Investigator (or designee) to be clinically significant, or QTcF interval of \> 450 msec for men or \> 470 msec for women. * Major surgery or major traumatic injury within 3 months of Day 1. Participants must have also fully recovered from any surgery and/or its complications before initiating the study treatment. * Malignancy or a history of malignancy prior to the Screening Visit (except for nonmelanoma cutaneous malignancies which have been fully treated and completed posttreatment follow-up). * History of or current active tuberculosis (TB) infection; history of latent TB or current latent TB infection as indicated by a positive QuantiFERON-TB test (or equivalent). * Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies at Screening visit as defined below: 1. Hepatitis B virus (HBV): Positive test for HBsAg. 2. HCV: Positive test for hepatitis C antibody and a positive test for HCV RNA. 3. HIV: Positive test for HIV antibody. * Other active infections or history of infections as follows: 1. Infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 14 days before the Baseline (Day 1) Visit. 2. A serious infection, defined as requiring hospitalization or IV anti-microbial therapy within 2 months prior to the Baseline (Day 1) Visit. 3. A history of opportunistic, recurrent, or chronic infections at Investigator's (or designee's) discretion. * History of significant allergy to any medication as judged by the Investigator (or designee). * Use of any prescription medication within 14 days prior to D1 or 5 half-lives, whichever is longer; or use of over-the-counter medications or supplements within 7 days prior to D1 (except for contraception, paracetamol and standard dose of multivitamins). * Participant has used more than 5 cigarettes per day, or equivalent with other nicotine containing products, in the 3 months prior to Day 1, or is unwilling to avoid nicotine use during confinement periods. * Participant who consumes on average more than 14 units of alcohol per week for female or 21 units of alcohol per week for male in the 6 months prior to Day 1 (1 unit = 10 mg alcohol), or who has a positive alcohol breath test at Screening or Day -1. * History of excessive or dependent alcohol or drug use or addiction issues in the two years prior to screening, or participants who are positive for drug testing at screening or Day-1. * Receipt of a live vaccine within 2 months prior to the Baseline visit (participants must agree to avoid live vaccination until at least 3 months after last dose of study drug). * Receipt of an inactivated vaccine such as COVID-19 vaccination or influenza vaccination, within 14 days prior or planning to receive inactivated vaccine within 14 days post study treatment administration. * Pregnant or lactating women. * Cannot commit to full participation in all trial procedures. * Any other circumstances that, in the Investigator (or designee) judgment, may increase the risk associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response. * Known exposure to anti-TL1A or any type of anti-TL1A therapy. * Known exposure to anti-IL23 or any type of anti-IL23 therapy. * Participants who have donated blood and/or plasma or lost a significant amount of blood (\> 400 mL) within 30 days prior to screening, or who plan to donate blood during the entire study period of 24 weeks (12 weeks for participants receiving placebo). * Participants who have received any other investigational agent or participated in any medical device clinical studies within 30 days or 5 half-lives, whichever is longer prior to screening.

Treatments Being Tested

DRUG

TL-003

Intravenously administered

DRUG

Placebo

Intravenously administered

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Linear Early Phase Ltd
Perth, Western Australia, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07526519), the sponsor (TrueLab Biopharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07526519 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07526519?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07526519?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07526519. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07526519. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.