Swedish Orphan Biovitrum
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.
Rare Diseases
NI-0501
Saline
Phase 1
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).
Study Type : | Interventional |
Estimated Enrollment : | 8 participants |
Masking: | Single |
Masking Description: | Double blind |
Primary Purpose: | Other |
Official Title: | 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. |
Actual Study Start Date : | January 14, 2021 |
Estimated Primary Completion Date : | June 25, 2021 |
Estimated Study Completion Date : | July 25, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: emapalumab emapalumab i.v infusion |
Drug: NI-0501 |
Placebo Comparator: Placebo Saline i.v. infusion |
Drug: Saline |
Ages Eligible for Study: | 20 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
P-One Clinic
Tokyo, Japan,