Single and multiple doses study of DS-5565 in healthy Chinese subjects

A randomized, placebo-controlled, double-blind study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of DS-5565 in healthy Chinese subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223624

Enrollment

Registered

2017-08-21

Start date

2017-09-04

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 volunteers

Interventions

investigational material(s) Generic name etc : DS-5565 INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Healthy Chinese 2)Aged 18 years to 45 years (inclusive), at the time of informed consent 3)Body weight of female >= 45 kg, male >= 50 kg, and a BMI in the range of 19.0 kg/m2 to 26.0 kg/m2 (inclusive) at screening

Exclusion criteria

Exclusion criteria: 1)Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy) 2)Presence or history of any drug abuse or of alcohol abuse etc.

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics Safety and pharmacokinetics	—

Countries

Asia except Japan

Outcome results

None listed

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