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Clinical Trial Summary

This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.


Clinical Trial Description

This study will assess the safety, PK, and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of DS-7011a in healthy participants. This study will be conducted in 3 stages: - Stage 1 - single ascending IV dose cohorts of DS-7011a (ie, up to 6 dose levels will be assessed starting at 0.1 mg/kg); - Stage 2 - single ascending SC cohorts of DS-7011a (ie, up to 3 dose levels centered around the estimated therapeutic dose confirmed in Stage 1 will be assessed); and - Stage 3 - a single IV cohort of DS-7011a in healthy participants of Japanese ethnicity (ie, 1 dose level at the estimated therapeutic dose as confirmed in Stage 1 will be assessed). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05203692
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 1
Start date February 2, 2022
Completion date March 22, 2023

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