Healthy VolunteersPhase 1NCT06867796

A Safety and Pharmacokinetics Study of TL-001 in Healthy Adults

A Phase 1 study testing TL-001 in people with Healthy Volunteers, run by TrueLab Biopharmaceutical Co., Ltd at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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-001 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 Volunteers
What is being tested?: TL-001
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: 2 Apr 2025to Dec 2028
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 as described in Section 3.7.
Of childbearing potential and agrees to practice abstinence or use highly effective contraception plus condom use as described in Section 3.7 consistently from 30 days prior to Day 1 to the EOS visit.

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Should not donate eggs from Day 1 until the EOS Visit.
Male participants must use condom if sexually active with females of childbearing potential. 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 (see Section 3.7) 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, ECG, thyroid ultrasound, and clinical laboratory tests obtained within 35 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.
Participants with a significant finding on history of thyroid conditions, thyroid function testing, thyroid antibody testing, or thyroid ultrasound giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.
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:
Participants with eGFR < 80 mL/min/1.73m2 as determined by the CKD-EPI 2021 formula, at the Screening or Baseline visits.

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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.
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/ALP, and no evidence of hemolysis, according to investigator (or designee) discretion.
White blood cell count < 3,000 cells/mm3 (< 3.0×109/L) or any abnormal evaluations judged clinically significant by the investigator (or designee) at the Screening or Baseline visits.
Abnormal lipase or amylase level that may interfere with the conduct or interpretation of the study according to investigator (or designee) discretion. 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 100-140 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 non-melanoma cutaneous malignancies which have been fully treated and completed post-treatment 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:
HBV: Positive test for hepatitis B surface antigen (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, antiparasitic, 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 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 (Repeat testing will be allowed by the investigator (or designee) discretion).
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.
Participants who have donated blood or lost a significant amount of blood (>400 mL) within 30 days prior to screening, or who plan to donate blood during the study.
Participants who have receipt of any study drug 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.

Australia1 site

B Block, Hospital Avenue
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of TL-001 in Healthy Adult Participants

Conditions: Healthy Volunteers
Being tested: TL-001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TL-001Drug
Intravenously administered
PlaceboDrug
Intravenously administered

Study groups in NCT06867796
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-001 or placebo. Receives: Drug: TL-001; 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-001 or placebo. Receives: Drug: TL-001; 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-001 or placebo. Receives: Drug: TL-001; 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-001 or placebo. Receives: Drug: TL-001; Drug: Placebo
MAD Cohort 1	Experimental	8 participants will receive in a 3:1 ratio of a multiple doses of MAD Dose Level 1 of TL-001 or placebo. Receives: Drug: TL-001; Drug: Placebo
MAD Cohort 2	Experimental	8 participants will receive in a 3:1 ratio of a multiple doses of MAD Dose Level 2 of TL-001 or placebo. Receives: Drug: TL-001; 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 337 Days

Secondary outcomes (10)

Time to maximum concentration (Tmax)
Time at which Cmax is observed after infusion (tmax)
Measured: Up to 337 Days
Maximum concentration (Cmax)
Maximum observed concentration (Cmax) after infusion
Measured: Up to 337 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 337 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 337 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 337 Days
Apparent clearance (CL)
The volume of plasma cleared of drug per unit time
Measured: Up to 337 Days
Apparent volume of distribution (Vz)
The theoretical volume into which a drug distributes in the body.
Measured: Up to 337 Days
Terminal elimination rate constant (λz)
The rate of drug elimination during the terminal phase of the concentration-time curve.
Measured: Up to 337 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 337 Days
Accumulation ratio (Rac)
The extent of drug accumulation at steady state compared to the first dose.
Measured: Up to 337 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 2025Dec 2028

First posted10 Mar 2025
Study start2 Apr 2025
Primary completionMar 2027 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06867796
Sponsor's protocol ID: TL-001-101
Status last verified: Sep 2026
First submitted: 4 Mar 2025
Last updated: 1 Oct 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 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 and Pharmacokinetics of TL-001 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT06867796
Acronym / sponsor ID: TL-001-101
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: TrueLab Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Tigermed Australia Pty Ltd
Study start: 2 Apr 2025 (actual)
Primary completion: Mar 2027 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 10 Mar 2025 (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.

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-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 1 of TL-001 or placebo.
SAD Cohort 2	Experimental	Drug: TL-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 2 of TL-001 or placebo.
SAD Cohort 3	Experimental	Drug: TL-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 3 of TL-001 or placebo.
SAD Cohort 4	Experimental	Drug: TL-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a single dose of SAD Dose Level 4 of TL-001 or placebo.
MAD Cohort 1	Experimental	Drug: TL-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a multiple doses of MAD Dose Level 1 of TL-001 or placebo.
MAD Cohort 2	Experimental	Drug: TL-001, Drug: Placebo8 participants will receive in a 3:1 ratio of a multiple doses of MAD Dose Level 2 of TL-001 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. 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 (see Section 3.7) 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 (36 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.
Participants with a significant finding on history of thyroid conditions, thyroid function testing, thyroid antibody testing, or thyroid ultrasound giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.
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:

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-001Intravenously 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 337 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 337 Days
Maximum concentration (Cmax)
Time frame: Up to 337 Days
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Up to 337 Days
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Up to 337 Days
Terminal half-life (t1/2)
Time frame: Up to 337 Days
Apparent clearance (CL)
Time frame: Up to 337 Days
Apparent volume of distribution (Vz)
Time frame: Up to 337 Days
Terminal elimination rate constant (λz)
Time frame: Up to 337 Days
Percentage of AUC0-inf obtained by extrapolation (%AUCex)
Time frame: Up to 337 Days
Accumulation ratio (Rac)
Time frame: Up to 337 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 1 Oct 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.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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-001 in people with Healthy Volunteers, 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 36 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 337 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06867796.

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 1 Oct 2026.