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A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT07300189•OrsoBio, Inc

View on ClinicalTrials.gov

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.

Detailed Description

The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-1180 in healthy subjects. The exploratory objective is to evaluate the PD of TLC-1180 in healthy subjects. This study is comprised of four parts: Part A (single-ascending dose), Part B (multiple-ascending dose), optional Part C (adaptive single- and/or multiple-ascending dose), and Part D (relative bioavailability of a tablet formulation of TLC-1180). Up to 72, 100, 100, and 8 healthy subjects will be recruited in Parts A, B, C, and D, respectively. The effect of food on TLC-1180 PK will also be evaluated in this study.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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)
+8 more criteria

Locations (1)

OrsoBio Research Site

Auckland, New Zealand

Key Dates

Start Date

October 20, 2025

Primary Completion Date

October 1, 2026

Completion Date

December 1, 2026

Last Updated

January 30, 2026

Enrollment

288

ESTIMATED participants

Conditions

Healthy Participants

Interventions

TLC-1180 Oral Solution

DRUG

TLC-1180 Tablet

DRUG

Placebo Oral Solution

OTHER

Placebo Tablet

OTHER

Contacts

Ryan Huss, MD

CONTACT

650-382-2225 Clinicaltrials_Inquires@orsobio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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