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First received: January 24, 2024

Clinical Trial: A First-In-Human Study of TAK-004 in Healthy Adults

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Volunteers

Study Type: INTERVENTIONAL


Official Title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-004 in Healthy Subjects

Brief Summary: This study is the first study with TAK-004 conducted in human beings.Participants will receive either TAK-004 or placebo.The main aim of this study is to learn how safe TAK-004 is in healthy adults and how well participants tolerate one or more doses of TAK-004.Other aims are to learn about the effects of TAK-004 on the heart rate and blood pressure and if TAK-004 creates an immune response (immunogenicity).Another aim is to learn how the body of healthy adults affects TAK-004 (pharmacokinetics).Participants will…

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