NCT04765553

A Study to Evaluate 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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.

Detailed description

This is a randomized, placebo-controlled and double-blinded study to evaluate the PK, PD and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects, performed in Japan. The subjects, 8 in total, will be randomized to receive either emapalumab or matching placebo in a 3:1 ratio (emapalumab: placebo).

Conditions

• Rare Diseases

Interventions

Type	Name	Description
DRUG	NI-0501	emapalumab single i.v infusion (1 mg/kg)
DRUG	Saline	Saline single i.v infusion

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-06-25
• Completion: 2021-07-25
• First posted: 2021-02-21
• Last updated: 2023-11-30
• Results posted: 2023-11-24

Locations

1 site across 1 country: Japan