DS-7011a for Lupus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
LupusDS-7011a - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
Select

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

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 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

Day 57
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Day 57
Number of Participants with Treatment-emergent Adverse Events Following Administration with DS-7011a in Healthy Participants
Day 9
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
Pharmacokinetic Parameter Terminal Half-life Following Administration of DS-7011a in Healthy Participants
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration Following Administration of DS-7011a in Healthy Participants

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

DS-7011a
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: DS-7011a · Has Placebo Group · Phase 1

DS-7011a
Drug
Experimental Group · 1 Intervention: DS-7011a · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
359 Previous Clinical Trials
341,695 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo, Inc.
151 Previous Clinical Trials
75,331 Total Patients Enrolled

Eligibility Criteria

Age 18 - 45 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 to 45 years of age (inclusive), with a body mass index (BMI) of 18 kg/m^2 to 30 kg/m^2 (inclusive) at Screening.
You are a woman of childbearing potential.