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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs DS 7011a (Primary) ; DS 7011a (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Adverse reactions; First in man
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 15 Nov 2023 Results assessing safety, PK, and PD, presented at the ACR Convergence 2023.
  • 15 Nov 2023 Results assessing PK and PD data from the non-Japanese HV (mainly Caucasian and African American) that were initially administered in this study IV doses of DS-7011a to select the doses for later SC administration to non-Japanese HV and IV administration to Japanese HV presented at the ACR Convergence 2023
  • 10 Apr 2023 Status changed from active, no longer recruiting to completed.

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