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Phase I PK/PD and safety study of emapalumab in Japanese healthy volunteers
jRCT2031200446Phase 1Completed
- Sponsor
- Sobi
- Start
- Feb 2021
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial in haemophagocytic lymphohistiocytosis (HLH) comparing emapalumab with placebo (2 arms). Primary endpoints: Pharmacokinetic parameters of emapalumab and Pharmacodynamic biomarkers of interferon-gamma pathway. Started Feb 2021; status: completed.
02
Drugs
emapalumab
03
Conditions
haemophagocytic lymphohistiocytosis (HLH)
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