Clinical Trials Logo

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 Contact for Clinical Trial Information
Phone 908-992-6400
Email [email protected]
Status Recruiting
Phase Phase 1
Start date February 2, 2022
Completion date December 2022

See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Completed NCT02554019 - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus Phase 2
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Not yet recruiting NCT03684564 - RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome Phase 2/Phase 3
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Recruiting NCT00527176 - Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity N/A
Completed NCT00519363 - Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors Phase 1/Phase 2