Actively Recruiting
A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects
Led by OrsoBio, Inc · Updated on 2026-04-14
288
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female subjects aged 18 to 55 years
- Non-smokers
- Body mass index between 19 and 35 kg/m2
- Estimated glomerular filtration rate at least 80 mL/min
- Normal liver biochemistry tests
- Normal or clinically insignificant 12-lead ECG
- Normal screening laboratory evaluations
- Females of childbearing potential with negative pregnancy tests at screening and admission
- Agreement to use specified contraception if sexually active
- In good health based on medical history and physical exam including vital signs
You will not qualify if you...
- Pregnant or lactating women
- Any serious or active medical or psychiatric illness interfering with study
- Use of investigational drugs within 30 days or 5 half-lives before dosing
- Current alcohol or substance abuse impacting compliance or safety
- Positive test for HIV-1, hepatitis B surface antigen, or hepatitis C antibody
- Use of prescription or over-the-counter medications within 28 days before dosing except allowed drugs
- Recent or planned use of systemic steroids, immunosuppressants, or chemotherapy
- History of serious skin diseases or drug allergies
- History or presence of significant cardiovascular disease or related conditions
- History of syncope, palpitations, or unexplained dizziness
- Implanted defibrillator or pacemaker
- History of liver diseases including autoimmune and other specific liver conditions
- History of rhabdomyolysis
- Severe peptic ulcer disease or other gastric acid disorders
- History of medical or surgical procedures altering intestinal absorption
- COVID-19 vaccination within 14 days before admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
OrsoBio Research Site
Auckland, New Zealand
Actively Recruiting
Research Team
R
Ryan Huss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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