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Monoclonal Antibodies

DS-7011a for Lupus

Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 1 and 3: pre-dose, end of infusion (eoi), and 1, 3, 6, 12, 24, 48, and 96 hours post-eoi, days 8, 11, 15, 22, 29, 36, and 57; stage 2: pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, days 9-12, 15, 22, 29, 36, and 57
Awards & highlights

Study Summary

This trial will study the effects of a new drug, DS-7011a, in healthy volunteers. Researchers will evaluate how safe the drug is, how it is processed by the body, and what effects it has.

Eligible Conditions
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 1 and 3: pre-dose, end of infusion (eoi), and 1, 3, 6, 12, 24, 48, and 96 hours post-eoi, days 8, 11, 15, 22, 29, 36, and 57; stage 2: pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, days 9-12, 15, 22, 29, 36, and 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 1 and 3: pre-dose, end of infusion (eoi), and 1, 3, 6, 12, 24, 48, and 96 hours post-eoi, days 8, 11, 15, 22, 29, 36, and 57; stage 2: pre-dose, and 1, 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose, days 9-12, 15, 22, 29, 36, and 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
Secondary outcome measures
Mean Interleukin (IL)-6 Levels Following Administration of DS-7011a in Healthy Participants
Pharmacokinetic Parameter Area Under the Concentration Curve Following Administration of DS-7011a in Healthy Participants
Pharmacokinetic Parameter Maximum Concentration Following Administration of DS-7011a in Healthy Participants
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DS-7011aExperimental Treatment1 Intervention
Stage 1: Healthy participants who will be randomized to receive a single intravenous (IV) ascending dose of DS-7011a (starting dose 0.1 mg/kg). Stage 2: Healthy participants who will be randomized to receive a single subcutaneous (SC) ascending dose of DS-7011a (starting dose will be centered around estimated therapeutic dose confirmed in Stage 1). Stage 3: Healthy Japanese participants who will be randomized to receive an IV dose of DS-7011a (based on estimated therapeutic dose confirmed in Stage 1).
Group II: PlaceboPlacebo Group1 Intervention
Healthy participants who will be randomized to receive a single dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DS-7011a
2022
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
416,221 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,078 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
162 Previous Clinical Trials
79,058 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current patient sample size for this research project?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, initially created on February 2nd 2022, is currently searching for participants. 80 people are needed from two different sites to participate in the study."

Answered by AI

Has DS-7011a attained federal certification as a safe pharmaceutical?

"Our team at Power assessed DS-7011a's safety on a scale from 1 to 3, and due to the fact that it is only in Phase 1 of clinical trials with limited data supporting its efficacy and safety, they have given it a score of one."

Answered by AI

Are there certain criteria to meet in order to qualify for participation in this research?

"This clinical trial is recruiting 80 individuals aged 18 to 45 years, suffering from lupus erythematosus systemic. Necessary criteria for applicants include: up-to-date COVID vaccination or prior recovery of SARS-CoV-2 infection; a negative serum pregnancy test at screening and urine pregnancy test on Day -1 (for women); surgically sterile men/women postmenopausal for 24 months with an FSH level ≥40 mIU/mL; males not donating sperm during the study period and 90 days after dose administration; overall good health without history of chronic disorders; confirmed Japanese ethnicity for Stage 3"

Answered by AI

Is enrollment for this investigation currently open?

"Clinicaltrials.gov affirms that this clinical trial is actively accepting participants, having first been posted on February 2nd 2022 and last modified November 11th of the same year."

Answered by AI

Is enrollment for this experiment available to individuals aged 20 and above?

"This trial has a minimum age qualification of 18 and a maximum cap of 45."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
2022. "A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203692.
~25 spots leftby May 2025
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