Systemic Lupus Erythematosus Clinical Trial
Official title:
A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of DS-7011a in Healthy Subjects
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.
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). ;
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