phase I study to evaluate pharmacokinetics, pharmacodynamics and safety of emapalumab in Japanese healthy volunteers.

A randomized, double-blinded, placebo-controlled, single center, phase I study to evaluate pharmacokinetics, pharmacodynamics and safety of emapalumab after a single intravenous dose in Japanese healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200446

Enrollment

Registered

2021-03-26

Start date

2021-02-05

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

Hemophagocytic Lymphohistiocytosis

Interventions

A single intravenous dose of 1 mg/kg of emapalumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers, age between 20 to 50 (inclusive)

Exclusion criteria

Exclusion criteria: Any clinically significant abnormality in the results of the safety laboratory tests. Subjects presenting a minor deviation from laboratory ranges could be enrolled if the investigator judge it to be non-clinically significant.

Design outcomes

Primary

Measure	Time frame
PK parameters: Cmax, tmax, CEOI, AUClast, AUCinf, %AUCextr, lambda-z, t1/2, CL, Vss, MRTlast and MRTinf PD biomarkers:Pre-dose circulating IFN-gamma concentration, Total IFN-gamma concentrations, CXCL9 concentration, sIL2R concentration	—

Secondary

Measure	Time frame
Adverse Events Laboratory parameters The presence of anti-drug antibodies (ADAs) and neutralizing antibodies (nAbs)	—

Contacts

Public ContactShimizu Yasuko

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-367798000

Outcome results

None listed

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