At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
NI-0501 +1 moredrug
Likely dose
NI-0501 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating NI-0501 and Saline for Rare Diseases. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRare Diseases
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartJan 2021
First PostedFeb 2021
Primary CompletionJun 2021
Study CompletionJul 2021
TodayJul 2026
First PostedFeb 21, 2021
Enrollment StartJan 14, 2021
Primary CompletionJun 25, 2021
Study CompletionJul 25, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.4 years ago
Interventions
NI-0501drug
emapalumab single i.v infusion (1 mg/kg)
Salinedrug
Saline single i.v infusion