NIPH Clinical Trials Search

Phase I Repeated Dose Study of TKT001-S

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Healthy adult males
Date of first enrollment	12/05/2025
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	Repeated doses of TKT001-S or TKT001-S placebo

Outcome(s)

Primary Outcome	Phamacokinetics,Safety,Tolerability
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	< 45age old
Gender	Male
Include criteria	Japanese healthy males between the age of 20 to under 45 years Those who the BMI between 18.5 kg/m^2to under 28.0 kg/m^2
Exclude criteria	Those with illnesses that may affect the evaluation of the drug History of hepatic, renal, or gastrointestinal or radiotherapy treatment that affects drug absorption Those with a history or suspected history of alcohol or drug abuse