Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled first-in-human (FIH) study of TRT-448 conducted in healthy adult participants. Key safety and tolerability assessments of TRT-448 will be regularly reviewed by an appointed Safety Review Committee (SRC). The study will be conducted in 2 parts: single ascending dose (SAD) and multiple ascending dose (MAD) healthy adult subject cohorts. Eligible subjects will be enrolled into a SAD cohort and will be randomized to receive a single dose of TRT-448 or placebo in a 3:1 ratio, respectively, via oral administration. Eligible participants will be enrolled into MAD cohorts and randomized to receive TRT-448 or placebo in a 3:1 ratio, respectively, once daily (QD) via oral administration from Day 1 and through Day 14 (MAD escalation cohorts) or from Day 1 through Day 28 (MAD expansion cohorts), inclusive. A total of up to 144 participants are planned to be enrolled. Each subject will be assessed for safety, pharmacokinetics and pharmacodynamics of TRT-448.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
Safety and tolerability of TRT-448 in healthy participants
Incidence of treatment-emergent adverse events
Time frame: Day 1 to Day 28
Cmax
Maximum observed serum concentration
Time frame: Day 1 to Day 28
Tmax
Time to reach maximum observed serum concentration
Time frame: Day 1 to Day 28
AUClast
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Time frame: Day 1 to Day 28
t1/2
Apparent first-order terminal elimination half-life
Time frame: Day 1 to Day 28
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