A phase I clinical trial of KSP-0576

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250154

Enrollment

256

Registered

2026-03-31

Start date

2026-04-01

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

interstitial cystitis/bladder pain syndrome

Interventions

KSP-0576 suspension will be administered orally to participants in single or multiple doses.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - At the time of informed consent, male aged >=18 and ==50 and =18.5 to =18.5 to =50 to =45 to <90 kg.

Exclusion criteria

Exclusion criteria: - Participants with abnormal findings on medical examination, vital signs, or 12-lead ECG, judged by the principal investigator or subinvestigator to be clinically significant.

Design outcomes

Primary

Measure	Time frame
- Incidence of adverse events and adverse drug reactions - Concentrations and pharmacokinetic parameters of KSP-0576	—

Secondary

Measure	Time frame
- Ratio of pharmacokinetic parameters of KSP 0576	—

Contacts

Public ContactYoshitaka Shimizu

Kissei Pharmaceutical Co., Ltd.

rinsyousiken@pharm.kissei.co.jp+81-3-5684-3533

Outcome results

None listed

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