Single and multiple oral doses of TLC-1180 in healthy adults

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-1180 in Healthy Subjects and an Open-Label Assessment of the Relative Bioavailability of, and Effect of Food on, a Tablet Formulation of TLC-1180

This trial will test whether single and repeated oral doses of TLC-1180 are safe and how the body processes them in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: OrsoBio, Inc (Industry-sponsored)
• Locations: 1 site (Auckland)
• Trial ID: NCT07300189 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, randomized, placebo-controlled study in healthy adults designed to characterize safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of TLC-1180. The protocol includes four parts: Part A (single-ascending doses), Part B (multiple-ascending doses), an optional adaptive Part C (single and/or multiple ascending doses), and Part D (relative bioavailability of a tablet formulation). Up to ~280 healthy volunteers may be enrolled across parts, and the study will also test the effect of food on PK. Participants will receive TLC-1180 oral solution or tablet or matching placebo under supervised conditions with scheduled safety and PK/PD sampling.

Who should consider this trial

Good fit: Ideal candidates are healthy, non-smoking adults aged 18–55 with BMI 19–35 kg/m2, normal labs, adequate kidney and liver function, a normal or clinically insignificant ECG, and agreement to protocol contraception if applicable.

Not a fit: People with active medical conditions, smokers, pregnant or breastfeeding women, children, or those outside the stated age/BMI/lab criteria are unlikely to gain any therapeutic benefit from participating.

Why it matters

Potential benefit: If successful, the study could identify safe dose ranges and how TLC-1180 behaves in the body, enabling dose selection for later patient trials.

How similar studies have performed: Single- and multiple-ascending dose Phase 1 designs are standard and have routinely succeeded in defining early safety, tolerability, and PK profiles for new drugs.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions
* History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery)
* Subjects who have received vaccination for COVID-19 within 14 days of Admission

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Auckland

• OrsoBio Research Site — Auckland, New Zealand (Recruiting)

Study contacts

• Study coordinator: Ryan Huss, MD

Conditions Healthy Participants