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drugset / Trial / NCT05642546

First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers

NCT05642546 ↗

Phase 1 Completed 40 enrolled NovelMed Therapeutics Labcorp Corporation of America Holdings, Inc · collab
RandomizedSequentialDouble-blindTreatment

Summary

This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).

Timeline

Start
2020-08-12
Primary completion
2022-06-15
Completion
2022-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject RUXOPRUBART Monoclonal antibody 0.3 mg/kg Intravenous
Subject RUXOPRUBART Monoclonal antibody 1 mg/kg Intravenous
Subject RUXOPRUBART Monoclonal antibody 3 mg/kg Intravenous
Subject RUXOPRUBART Monoclonal antibody 10 mg/kg Intravenous
Subject RUXOPRUBART Monoclonal antibody 20 mg/kg Intravenous

Indications

No indication recorded.