This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts,
each with a specific primary objective:
Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part
B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To
characterise the food effect of TTYP01 tablets in healthy adult subjects under the fasted or
fed condition.
The secondary objectives of the study are to evaluate the pharmacokinetic (PK) profiles of
TTYP01 tablets in healthy adult subjects, and the effects of gender on the PK of TTYP01
tablets in healthy adults. In Part A of the study, a total of 32 healthy adult subjects will
be enrolled over four consecutive cohorts (8 per cohort), with participants receiving a
single dose of TTYP01 at one of four levels (60, 120, 10 or 240 mg), to assess the PK and
safety of TTYP01. In Part B, 16 healthy adults will be randomized into 2 groups, and the
comparison of the PK of edaravone (TTYP01 and intravenous (IV) edaravone) will be evaluated
using a randomized, open-label, four-period crossover design under fasted conditions. In the
first crossover period, subjects will receive a single fixed dose of TTYP01 followed by the
alternate IV dose after completion of the washout phase, and in the second crossover period,
subjects will receive a higher fixed dose of TTYP01 followed by the alternate IV dose after
completion of the washout phase. In Part C, 18 healthy subjects will be enrolled to evaluate
the effect of food on the PK of TTYP01 using a randomized, open-label, two-period cross-over
design. Participants will be randomized into two groups and administered a fixed dose of
TTYP01 on Day 1 (Period 1) under the fed conditions and the second dosing day (Period 2)
under the fasted conditions, while the other group being administered a fixed dose of TTYP01
on Day 1 (Period 1) under the fasted conditions and the second dosing day (Period 2) under
the fed conditions.
Phase:
Phase 1
Details
Lead Sponsor:
Auzone Biological Technology Pty Ltd
Collaborators:
CMAX Clinical Research Pty Ltd TIGERMED AUSTRALIA PTY LIMITED