Phase I Repeated Dose Study of TKT001-S

A Phase I, randomized, double-blind, placebo-controlled, comparative study to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of TKT001-S in healthy Japanese adult males.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240129

Enrollment

Registered

2025-03-14

Start date

2025-05-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult males

Interventions

Repeated doses of TKT001-S or TKT001-S placebo

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Phamacokinetics,Safety,Tolerability	—

Contacts

Public ContactShigeto Mashimo

Seren Pharmaceuticals Inc.

mashimo@serenpharma.com+81-3-5244-9343

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026