DS-7011a for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DS-7011a to evaluate its safety and the body's response. Healthy participants will receive varying doses of the treatment, either through an IV or an injection under the skin, to determine the optimal dose. Participants will be randomly assigned to receive either the treatment or a placebo, which serves as a control. This study targets healthy individuals without chronic conditions who are fully vaccinated against COVID-19 or have recovered from it. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have used systemic corticosteroids or immunosuppressive agents. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that DS-7011a is likely to be safe for humans?
Research has shown that DS-7011a is generally safe for people. In earlier studies, most participants experienced only mild side effects, which the drug did not cause. This suggests that DS-7011a is likely well-tolerated even at higher doses. The safety results are encouraging, with no serious side effects reported.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about DS-7011a because it introduces a potentially new mechanism of action in treating its target condition. While most standard treatments rely on established pathways, DS-7011a offers a unique approach by utilizing a novel active ingredient. Additionally, DS-7011a is being tested in both intravenous and subcutaneous delivery forms, which could provide greater flexibility and convenience for patients compared to current options. This versatility and innovative approach are what make DS-7011a stand out in the field.
What evidence suggests that DS-7011a could be effective?
Research has shown that DS-7011a appears promising in early studies for treating conditions like systemic lupus erythematosus (SLE). In this trial, participants will receive either DS-7011a or a placebo. Earlier studies found that DS-7011a was generally safe and well-tolerated. Fewer participants experienced side effects compared to those who received a placebo, with 33.3% experiencing side effects versus 45.0% for placebo recipients. The body processed the treatment well, and it had positive effects, making it a candidate for further development. These findings are encouraging, but more research is needed to confirm its effectiveness for specific conditions.14678
Who Is on the Research Team?
Global Clinical Leader
Principal Investigator
Daiichi Sankyo
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 - Treatment
Single ascending intravenous (IV) dose cohorts of DS-7011a are administered to healthy participants
Stage 2 - Treatment
Single ascending subcutaneous (SC) dose cohorts of DS-7011a are administered to healthy participants
Stage 3 - Treatment
Single IV dose of DS-7011a is administered to healthy participants of Japanese ethnicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DS-7011a
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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).
Healthy participants who will be randomized to receive a single dose of placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Daiichi Sankyo, Inc.
Lead Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Citations
A Study of DS-7011a in Patients With Systemic Lupus ...
This Phase 1b/2 study will initially explore the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of DS-7011a in patients ...
First‐in‐Human Study of the Safety, Tolerability ...
DS-7011a resulted in AEs in 33.3% of the DS-7011a-treated HS who received it, compared to 45.0% of the placebo-treated HS. These AEs were ...
L.
DS-7011a was generally safe and well tolerated and showed optimal pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in a first-in-human (FIH), ...
Scientific Abstracts 963
DS-7011a was generally safe and well tolerated and showed optimal pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in a first-in- ...
First-in-Human Study of the Safety, Tolerability ...
DS-7011a showed favorable safety, pharmacokinetics, immunogenicity, and PD properties that support its development for the treatment of SLE.
A Study of DS-7011a in Patients With Systemic Lupus ...
This Phase 1b/2 study will initially explore the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of DS-7011a in patients ...
Abstract
DS-7011a was generally safe and well tolerated and showed optimal pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in a first-in-human (FIH), ...
Anti-human TLR7 antibody for therapeutic intervention in ...
In a Phase 1a study (NCT05203692), DS-7011a was generally safe and well tolerated (33). DS-7011a also dose-dependently suppressed TLR7-mediated ...
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