A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
NCT05203692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-04-11
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.
Conditions
Interventions
- DRUG
-
DS-7011a
Intravenous or subcutaneous administration, single dose
- DRUG
-
Intravenous or subcutaneous administration, single dose
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-02
- Primary Completion
- 2023-01-25
- Completion
- 2023-03-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
NCT02321709 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
NCT05203419 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants
NCT05278663 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
NCT06013995 ·Status: RECRUITING ·Phase: PHASE1
-
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
NCT07306585 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
NCT02331810 ·Status: WITHDRAWN ·Phase: PHASE1
-
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
NCT00960362 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
NCT07323173 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of CC312 for Moderate to Severe SLE
NCT07177911 ·Status: RECRUITING ·Phase: PHASE1
-
Single Ascending Dose Study of AMG 570 in Healthy Subjects
NCT02618967 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
NCT04963296 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
NCT03933943 ·Status: COMPLETED ·Phase: PHASE1
-
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
NCT03771885 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
NCT02291588 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
NCT02920424 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
NCT02411136 ·Status: COMPLETED ·Phase: PHASE1
-
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
NCT01300208 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT01196091 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
NCT04924296 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of M5049 in CLE and SLE Participants
NCT04647708 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus
NCT02443506 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
NCT02391259 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus
NCT01702740 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
NCT03451422 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
NCT01093911 ·Status: COMPLETED ·Phase: PHASE1