Pharmacokinetic Study of NaPPS in Healthy Adult Males Comparative Examination of Plasma and Urine Concentration in Repeated Subcutaneous and Oral Administration

Status

Active, not recruiting

Phases

Phase 1

Study type

Unknown

Source

JPRN

Registry ID

JPRN-jRCT2031250218

Enrollment

Registered

2025-07-07

Start date

2025-05-23

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 volunteer

Interventions

1. Subcutaneous Administration Group A subject is subcutaneously administered NaPPS once a week for 8 weeks (8 times in total). 2. Oral Administration Group A subject take one capsule 3times a day w

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese male aged from 18 to 35 years 2) A subject with a body mass index (BMI) of 18.5 to less than 25.0 at the time of screening tests

Exclusion criteria

Exclusion criteria: 1) A subject with a history or symptoms of liver, kidney, heart, lung, gastrointestinal, or blood coagulation disorders 2) A subject with hemorrhoids and diseases accompanied by gastrointestinal bleeding 3) A subject who have undergone surgical procedures within 6 months before administration of the investigational drug 4) A subject with hemorrhagic diathesis 5) A subject with Maculopathy (including suspected)

Design outcomes

Primary

Measure	Time frame
[Plasma Concentration] AUC, Cmax	—

Secondary

Measure	Time frame
[Plasma Concentration] Tmax, MRT, t1/2, kel, Vss, CL [Urine Concentration] PK parameters	—

Contacts

Public ContactMaki Urata

ReqMed Company, Ltd.

urata@reqmed.co.jp+81-42-732-2207

Outcome results

None listed

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