A Phase I Study of OJI-220 in Healthy Japanese Adult Male Subjects (Single Intravenous Administration Study)

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Administration of OJI-220 in Healthy Japanese Adult Male Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071260003

Enrollment

Registered

2026-04-03

Start date

2026-04-15

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

Single intravenous administration of OJI-220 in healthy adult male subjects.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Subjects who provided written informed consent prior to participation in the study. 2. Japanese healthy adult male subjects 3. Subject aged >=18 and = 18.5 kg/m2 and <25.0 kg/m2 at screening.

Exclusion criteria

Exclusion criteria: 1. Subjects with a history or presence of clinically significant neurological, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or psychiatric disorders. 2. Subjects who regularly use prescription or non-prescription medications. 3. Subjects with a history of major bleeding, severe trauma, or major surgery of any type within 6 months prior to study drug administration.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics	—

Contacts

Public ContactClinical Development Department

Oji Pharma Co., Ltd

ojipharma-cd@oji-gr.com+81-3-3520-9888

Outcome results

None listed

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