Healthy volunteers Other
Conditions
Interventions
The study will proceed in four parts (Parts A-D), where Parts A-C are randomized, blinded (sponsor-unblinded), placebo-controlled, and Part D is open-label. Part A will evaluate the safety, tolerabili
Sponsors
OrsoBio, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive 2. Body mass index from 19 to 35 kg/m2, inclusive 3. Estimated glomerular filtration rate = 80 mL/min 4. Normal liver biochemistry tests 5. 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 6. Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator 7. Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission 8. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception 9. Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating subjects 2. 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 3. Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing 4. Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety 5. Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety 6. A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody 7. 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 8. 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) 9. 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 10. Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) 11. 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 12. Syncope, palpitations, or unexplained dizziness 13. Implanted defibrillator or pacemaker 14. 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) 15. History of rhabdomyolysis 16. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions 17. History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery) 18. Subjects who have received vaccination for COVID-19 within 14 days of Admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 10/04/2026: 1. 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. [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 2. PK of TLC-1180 AUC: Area under the concentration-time curve [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 3. PK of TLC-1180 Cmax: Maximum plasma concentration [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 4. PK of TLC-1180 tmax: Time to reach Cmax [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 5. PK of TLC-1180 t1/2: Half-life [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 6. PK of TLC-1180 CL/F: Apparent clearance, calculated as dose/AUC0-inf [Time Frame: Through study completion: Day 365 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] Previous primary outcomes: 1. 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. [Time Frame: Through study completion: Day 15 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 2. PK of TLC-1180 AUC: Area under the concentration-time curve [Time Frame: Through study completion: Day 15 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] 3. PK of TLC-1180 Cmax: Maximum plasma concentration [Time Frame: Through study completion: Day 15 (Parts A, C); Day 28 (Parts B, C); Day 39 (Part D) of the study] | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
New Zealand
Contacts
Public ContactClinical Trials
Outcome results
None listed