Healthy VolunteerPhase 1NCT07526519
A Safety and Pharmacokinetics Study of TL-003 in Healthy Adults and Open-label Assessments in Participants With Ulcerative Colitis
A Phase 1 study testing TL-003 in people with Healthy Volunteer, run by TrueLab Biopharmaceutical Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TL-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Apr 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Not of childbearing potential
- 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.
Show all 9Show fewer
- 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 cannot join
- 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:
- 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.
- 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.
Show all 35Show fewer
- 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.
- 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:
- Hepatitis B virus (HBV): Positive test for HBsAg.
- HCV: Positive test for hepatitis C antibody and a positive test for HCV RNA.
- HIV: Positive test for HIV antibody.
- Other active infections or history of infections as follows:
- Infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 14 days before the Baseline (Day 1) Visit.
- A serious infection, defined as requiring hospitalization or IV anti-microbial therapy within 2 months prior to the Baseline (Day 1) Visit.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Linear Early Phase Ltd
Perth, Western Australia, 6009
About this study
Official title: 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
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
- Being tested
- TL-003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL-003Drug
Intravenously administered
PlaceboDrug
Intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 1 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
| SAD Cohort 2 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 2 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
| SAD Cohort 3 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 3 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
| SAD Cohort 4 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 4 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
| MAD Cohort 1 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of MAD Dose Level 1 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
| MAD Cohort 2 | Experimental | 8 participants will receive in a 3:1 ratio of a single dose of MAD Dose Level 2 of TL-003 or placebo. Receives: Drug: TL-003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment Emergent Adverse Events adverse events (TEAEs)
Incidence and severity of AEs, including clinical relevant findings from the clinical laboratory tests (hematology, urinalysis, blood chemistry), physical examination, vital signs, 12-lead ECGs.
Measured: Up to 169 Days
Secondary outcomes (10)
Time to maximum concentration (Tmax)
Time at which Cmax is observed after infusion (tmax)
Measured: Up to 169 Days
Maximum concentration (Cmax)
Maximum observed concentration (Cmax) after infusion
Measured: Up to 169 Days
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
The area under the plasma concentration-time curve from time 0 to the last measurable time-point (AUC0-t).
Measured: Up to 169 Days
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
Measured: Up to 169 Days
Terminal half-life (t1/2)
The time required for the plasma concentration of the drug to decrease by 50% during the terminal elimination phase
Measured: Up to 169 Days
Apparent clearance (CL)
The volume of plasma cleared of drug per unit time.
Measured: Up to 169 Days
Apparent volume of distribution (Vz)
The theoretical volume into which a drug distributes in the body.
Measured: Up to 169 Days
Terminal elimination rate constant (λz)
The rate of drug elimination during the terminal phase of the concentration-time curve.
Measured: Up to 169 Days
Percentage of AUC0-inf obtained by extrapolation (%AUCex)
Percentage of the area under the concentration-time curve from time zero to infinity obtained by extrapolation (%AUCex)
Measured: Up to 169 Days
Accumulation ratio (Rac)
The extent of drug accumulation at steady state compared to the first dose.
Measured: Up to 169 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start8 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TrueLab Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SAPRO Consulting Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526519
- Sponsor's protocol ID
- TL-003-101
- Status last verified
- May 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: TrueLab will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07526519
- Acronym / sponsor ID
- TL-003-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- TrueLab Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- SAPRO Consulting Pty Ltd
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 1 of TL-003 or placebo. |
| SAD Cohort 2 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 2 of TL-003 or placebo. |
| SAD Cohort 3 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 3 of TL-003 or placebo. |
| SAD Cohort 4 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 4 of TL-003 or placebo. |
| MAD Cohort 1 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of MAD Dose Level 1 of TL-003 or placebo. |
| MAD Cohort 2 | Experimental | Drug: TL-003, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of MAD Dose Level 2 of TL-003 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (35 listed)
- 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:
- Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic, heart rate 40-100 beats/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL-003Intravenously administered | Drug | MAD Cohort 1, MAD Cohort 2, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4 |
| PlaceboIntravenously administered | Drug | MAD Cohort 1, MAD Cohort 2, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4 |
Primary outcome
Incidence and severity of Treatment Emergent Adverse Events adverse events (TEAEs)
Time frame: Up to 169 Days
Incidence and severity of AEs, including clinical relevant findings from the clinical laboratory tests (hematology, urinalysis, blood chemistry), physical examination, vital signs, 12-lead ECGs.
10 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Up to 169 Days
Maximum concentration (Cmax)
Time frame: Up to 169 Days
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Up to 169 Days
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Up to 169 Days
Terminal half-life (t1/2)
Time frame: Up to 169 Days
Apparent clearance (CL)
Time frame: Up to 169 Days
Apparent volume of distribution (Vz)
Time frame: Up to 169 Days
Terminal elimination rate constant (λz)
Time frame: Up to 169 Days
Percentage of AUC0-inf obtained by extrapolation (%AUCex)
Time frame: Up to 169 Days
Accumulation ratio (Rac)
Time frame: Up to 169 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. TrueLab will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TL-003 in people with Healthy Volunteer, run by TrueLab Biopharmaceutical Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Schrader, Doctor of Medicine (61 08 63825100, pschrader@linear.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment Emergent Adverse Events adverse events (TEAEs) (time frame: Up to 169 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.