Phase I Single-Administration Study of TKT001-S

A phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of TKT001-S following a single escalating dose administration in healthy Japanese male subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071230046

Enrollment

Registered

2023-07-25

Start date

2023-09-26

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

Single dose 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 to under 28.0

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