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Safety Tolerability and Pharmacokinetics of SCTA01 an Anti-SARS-CoV-2 Monoclonal Antibody in Healthy Chinese Subjects

Safety Tolerability and Pharmacokinetics of SCTA01 an Anti-SARS-CoV-2 Monoclonal Antibody in Healthy Chinese Subjects

Recruiting
18 years and older
All
Phase 1
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  • Technical description (Original)

This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.

Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort.

An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.

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Study details
    Coronavirus Disease 2019

NCT04483375

Sinocelltech Ltd.

19 February 2024

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