Trial intelligence / Profile preview

SYN023 Bridging Study in Healthy Adults

NCT04495569Phase 2

Key facts

Status: Completed
Start: Feb 2019
Primary completion: Jun 2019
Countries: 1
Sponsor: Xingmeng Biopharmaceutical
Modality: Bispecific Antibodies, Monoclonal Antibodies

Drugs: zamerovimab + mazorelvimab
Conditions: rabies

Overview

Phase 2, open-label trial of zamerovimab + mazorelvimab in rabies (2 cohorts), sponsored by Xingmeng Biopharmaceutical. Primary endpoints: Time to Maximum Concentration at 85 days, Maximum Plasma Concentration at 85 days and 3 more. Started Feb 2019; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort A
SYN023 0.3mg/kg alone
Cohort B
SYN023 0.3mg/kg + Rabies Vaccine

Endpoints

Primary

Time to Maximum Concentration85 days
Maximum Plasma Concentration85 days
Half-Life85 days
Clearance Rate85 days
Area Under the Curve85 days

Secondary

Adverse Event Incidence85 days
Rabies Virus Neutralizing Antibodies >= 0.5 IU/mL85 days
Rabies Virus Neutralizing Antibodies Levels85 days
Anti-Drug Antibodies85 days

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