WHO ICTRP trial

A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled…

NL-OMON46244 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting

Key facts

Trial ID NL-OMON46244
Public title A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects.
Scientific title A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects. - APX001 First in human study.
Primary sponsor Amplyx Pharmaceuticals, Inc.
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Not Recruiting
Study type Interventional
Countries The Netherlands
Conditions Fungal diseases.;10003816;Fungal diseases.
Interventions SAD: Cohort 1: 1 x 10 mg Cohort 2: 1 x 30 mg Cohort 3: 1 x 100 mg Cohort 4: 1 x 300 mg Cohort 5: 1 x 525 mg Cohort 6: 1 x 800 mg MAD: Cohort 7: 1 x 50 mg Cohort 8: tbd x tbc mg Cohort 9: tbc x tbc mg Cohort 10: tbc x tbc mg Cohort 11: tbd…
Registration date Apr 11, 2017
Target size 120
Secondary IDs 2016-000974-39;NL57571.056.16
Registry page onderzoekmetmensen.nl

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