NCT04370431 - A Study of TTYP01 in Healthy Adult Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 24, 2020

Primary Completion Date

December 17, 2020

Study Completion Date

January 8, 2021

Conditions

Healthy Adult Subjects

Interventions

DRUG

TTYP01 single ascending doses

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)

DRUG

Placebo

Placebo control for Part A of the study

DRUG

TTYP01, 60 mg

TTYP01 oral tablets (30 mg edaravone per tablet)

DRUG

TTYP01, 120 mg

TTYP01 oral tablets (30 mg edaravone per tablet)

DRUG

Radicut® (ampoule), 30 mg

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

DRUG

Radicut® (bag) , 60 mg

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

DRUG

TTYP01, up to 120 mg

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)

Trial Locations (1)

5000

CMAX Clinical Research Pty Ltd, Adelaide