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Kallikrein 5 Inhibitor

A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects

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 day 1: pre-dose & 4, 8, 24, 72, 96, 120, 144 hours (hr) post-dose; day 8 & 14: pre-dose; day 22: pre-dose & 4, 8, 24, 48, 72, 96, 120, 144, 168 hr post-dose; day 36, 43, 57, & 78

Summary

This trial is testing a new drug called DS-2325a for treating Netherton syndrome, a rare skin disorder. The drug works by blocking a protein that causes skin issues. The study will check if the drug is safe and how it behaves in the body when given to healthy people.

Eligible Conditions
  • Netherton Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-dose & 4, 8, 24, 72, 96, 120, 144 hours (hr) post-dose; day 8 & 14: pre-dose; day 22: pre-dose & 4, 8, 24, 48, 72, 96, 120, 144, 168 hr post-dose; day 36, 43, 57, & 78
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pre-dose & 4, 8, 24, 72, 96, 120, 144 hours (hr) post-dose; day 8 & 14: pre-dose; day 22: pre-dose & 4, 8, 24, 48, 72, 96, 120, 144, 168 hr post-dose; day 36, 43, 57, & 78 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325a
Secondary study objectives
Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Pharmacokinetic Parameter Area Under the Concentration Curve (AUCtau)
Pharmacokinetic Parameter Average Concentration (Cavg)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo SCExperimental Treatment1 Intervention
Participants who will be randomized to receive placebo as a subcutaneous (SC) injection.
Group II: DS-2325a SCExperimental Treatment1 Intervention
Participants who will be randomized to receive DS-2325a as a fixed dose subcutaneous (SC) injection (starting dose 300 mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
DS-2325a
2022
Completed Phase 1
~90

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
418 Previous Clinical Trials
468,543 Total Patients Enrolled
2 Trials studying Netherton Syndrome
73 Patients Enrolled for Netherton Syndrome
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,896 Total Patients Enrolled
2 Trials studying Netherton Syndrome
73 Patients Enrolled for Netherton Syndrome
Clinical DirectorStudy DirectorDaiichi Sankyo
18 Previous Clinical Trials
4,772 Total Patients Enrolled
1 Trials studying Netherton Syndrome
64 Patients Enrolled for Netherton Syndrome
~8 spots leftby Dec 2025
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