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

NCT06867796 | Not Yet Recruiting Phase 1

• 1 other identifier: TL-001-101
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 337 Days

Secondary Outcomes (10)

• Time to maximum concentration (Tmax)

  Up to 337 Days

• Maximum concentration (Cmax)

  Up to 337 Days

• Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)

  Up to 337 Days

• Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

  Up to 337 Days

• Terminal half-life (t1/2)

  Up to 337 Days

Other Outcomes (3)

• Change from baseline in the serum concentration of pre-specified pharmacodynamic biomarker over time

  Up to 337 Days

• Incidence of anti-drug antibody (ADA)

  Up to 337 Days

• Titer of anti-drug antibody (ADA)

  Up to 337 Days

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: TL-001; Drug: Placebo

Interventions

TL-001 DRUG

Intravenously administered

MAD Cohort 1; MAD Cohort 2; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4

Placebo DRUG

Intravenously administered

MAD Cohort 1; MAD Cohort 2; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• TrueLab Biopharmaceutical Co., Ltd: lead
• Tigermed Australia Pty Ltd: collaborator

Central Study Contacts

Ana L.A. Sun, Doctor of Medicine

CONTACT

61 08 63825100; asun@linear.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share