A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers

A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers - A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018828

Enrollment

Registered

2015-09-01

Start date

2015-12-01

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

Acute myocardial infarction

Interventions

OSKLIPO-0524 0.15 mg/kg, single administration OSKLIPO-0524 0.5 mg/kg, single administration OSKLIPO-0524 1.0 mg/kg, single administration Placebo

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Japanese healthy male age >=20 years and <= 40 years old at the time of informed consent 2)Japanese healthy male who passes screening tests and examination before administration of the drug 3)After receiving a sufficient explanation upon participation in this trial, on a full understanding, Japanese healthy male who obtained the written informed consent from each subject

Exclusion criteria

Exclusion criteria: 1) A subject who has cardiovascular,kidney, liver, blood or autoimmune system diseases 2) BMI (kg/m2) <17.5 or >=30.0 3) A subject who has HCV Ab, HIV Ab, HBs Ag positive by screening test 4) A subject who has or is suspected to have the past of clinically significant drug allergy symptoms 5) A subject who has or is suspected to have the past of significant allergic diseases including bronchial asthma, urticaria or atopy, but not seasonal allergy 6) A subject with diseases and symptoms requiring systemic drugs 7) A subject who has or suspeted to have a past histroy of drug or alcohol dependency 8) A subject who received vaccine within four months 9) A subject who participated in other clinical trials within 4 months and received a clinical trial drug (including a placebo) 10) A subject taking prescribed drugs and/or Over-The-Counter drugs 11) Ineligible judged by the investigators

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters (Cmax, T1/2, AUC) of cyclosporine	—

Secondary

Measure	Time frame
Saftey	—

Countries

Japan

Contacts

Public ContactDaisaku Nakatani

Osaka University Graduate School of Medicine Department of Cardiovascular Medicine

nakatani@cardiology.med.osaka-u.ac.jp+81-6-6210-8289

Outcome results

None listed

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