A Study of TTYP01 in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): TTYP01 single ascending doses; Placebo; TTYP01, 60 mg; TTYP01, 120 mg; Radicut® (ampoule), 30 mg; Radicut® (bag) , 60 mg; TTYP01, up to 120 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose); Placebo control for Part A of the study; TTYP01 oral tablets (30 mg edaravone per tablet); TTYP01 oral tablets (30 mg edaravone per tablet); An intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes; An intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes; TTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg)
Other intervention name(s): edaravone tablet; Edaravone tablet; Edaravone tablet; Edaravone injection; Edaravone injection; Edaravone tablet
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment