A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOrsoBio, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TLC-1180 Oral Solution
- TLC-1180 Tablet
- Placebo Oral Solution
- Placebo Tablet
Treatment groups
288 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov