A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers

A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers - Intravenous Administration of NK-104-NP to healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014940

Enrollment

Registered

2014-08-25

Start date

2014-09-03

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

Pulmonary Hypertension

Interventions

NK-104-NP 1mg NK-104-NP 2mg NK-104-NP 4mg NK-104-NP 8mg

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Healthy Male Japanese 2)A person aged 20yo to 40yo 3)A person with a BMI values under 18.5 or over 30.0

Exclusion criteria

Exclusion criteria: 1)A person who has history of drug allergy. 2)A person who has hypersensitivity including allergy (except asymptomatic allergy). 3)A person who used other therapeutic drugs within 2 weeks or who needs other therapeutic drugs during the clinical trial participation period. 4)A person who used other OTC drugs within a week or who needs other OTC drugs during the clinical trial participation period. 5)A person who donated over 200 mL of whole blood within a month, who experienced plasmapheresis/platelet apheresis within 2 weeks or who donated over 400 mL of whole blood within 3 months. 6)A person who was entolled and given new drugs in other clinical trials within four months before this clinical trial or a person who participates in other clinical trials at the same time with this clinical trial. 7)A person whose percutaneous arterial oxygen saturation is less than 95%. 8)A person with alcohol or drug dependency. 9)A person who is positive for drug abuse tests. 10)A person who is positive for the following tests: HBs antigen, HCV antibody, HIV antigen/antibody or syphilis serum reaction. 11)A person who cannot prevent pregnancy during 6 months after this clinical trial. 12)A person assessed as ineligible for enrollment by investigators of this clinical trial.

Design outcomes

Primary

Measure	Time frame
Names, severity and incidence rate of adverse effect and adverse drug reactions.	—

Countries

Japan

Contacts

Public ContactKaku Nakano

Kyushu University Department of Cardiovascular Research, Development, and Translational Medicine

kaku@cardiol.med.kyushu-u.ac.jp092-642-6919

Outcome results

None listed

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