New drug TLC-1180 tested in healthy people for first time
NCT ID NCT07300189
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new drug called TLC-1180 in 288 healthy adults aged 18 to 55. The main goal is to check if the drug is safe and how the body handles it, not to treat any disease. Participants will receive either the drug or a placebo, and researchers will monitor side effects and measure drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLC-1180
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 332 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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OrsoBio Research Site
RECRUITINGAuckland, New Zealand
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