A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects

NCT07300189 | Recruiting Phase 1

• 1 other identifier: 1180-CL-101
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

• Incidence of TLC-1180 treatment-emergent adverse events

  Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

• PK of TLC-1180 AUC

  Area under the concentration-time curve

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

• PK of TLC-1180 Cmax

  Maximum plasma concentration

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

• PK of TLC-1180 tmax

  Time to reach Cmax

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

• PK of TLC-1180 t1/2

  Half-life

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

• PK of TLC-1180 CL/F

  Apparent clearance, calculated as dose/AUC0-inf

  Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study

Study Arms (2)

Oral Solution

EXPERIMENTAL

Oral solution of TLC-1180

Drug: TLC-1180 Oral Solution; Other: Placebo Oral Solution

Tablet

EXPERIMENTAL

Tablet formulation of TLC-1180

Drug: TLC-1180 Tablet; Other: Placebo Tablet

Interventions

TLC-1180 Oral Solution DRUG

Oral solution of TLC-1180

Oral Solution

TLC-1180 Tablet DRUG

Tablet formulation of TLC-1180

Tablet

Placebo Oral Solution OTHER

Placebo-to-match oral solution TLC-1180

Oral Solution

Placebo Tablet OTHER

Placebo-to-match tablet formulation of TLC-1180

Tablet

Eligibility Criteria

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

You may qualify if:

• Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive
• Body mass index from 19 to 35 kg/m2, inclusive
• Estimated glomerular filtration rate ≥ 80 mL/min
• Normal liver biochemistry tests
• Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance
• Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
• Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission
• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
• Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs

You may not qualify if:

• Pregnant or lactating subjects
• Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol
• Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing
• Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
• A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody
• Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen (paracetamol), ibuprofen, and/or hormonal contraceptive medications
• Subjects who have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
• Medical history of serious skin disease in the opinion of the investigator, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
• Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
• Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and/or clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction \< 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
• Syncope, palpitations, or unexplained dizziness
• Implanted defibrillator or pacemaker
• Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency)
• History of rhabdomyolysis

Sponsors & Collaborators

• OrsoBio, Inc: lead

Study Sites (1)

OrsoBio Research Site

Auckland, New Zealand

RECRUITING

Central Study Contacts

Ryan Huss, MD

CONTACT

650-382-2225; Clinicaltrials_Inquires@orsobio.com

Study Design

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

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)