A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers
brief summary
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers
detailed description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers. The study will be conducted in 1 part only, as a single ascending dose (SAD) study at up to 4 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (With Optional Food Effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers