Phase 1 – testing safety in a small group of people
Conditions:
Healthy
Sponsor: Terran Biosciences Australia Pty Ltd
trial.available_in:
БГ
Overview
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.
Who can participate
Inclusion Criteria:
* BMI between 18 and 32 kg/m2
* Medically healthy without clinically significant or relevant medical history
Exclusion Criteria:
* Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
* Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
* Impaired renal function
* Cardiac abnormalities
* Positive HIV, HBsAg or HCV
* Positive test for alcohol, drugs of abuse or cotinine
БГ