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Kallikrein 5 Inhibitor

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

Phase 1
Waitlist Available
Research Sponsored by Daiichi Sankyo, Inc.
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 sc and iv cohorts: day 1 pre-dose and 1, 2, 4, 8 hours (hr) post-dose; 24, 48, 96, 120, 144, 168, 192, 240, 288, 336, 384, 432, 480, 552, 624, 696, 768, 840, 1008, 1176, 1344 hr post-dose

Summary

This trial is testing a new drug called DS-2325a to treat Netherton syndrome, a rare skin condition. The drug aims to help by blocking an enzyme that causes problems in these patients.

Eligible Conditions
  • Netherton Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sc and iv cohorts: day 1 pre-dose and 1, 2, 4, 8 hours (hr) post-dose; 24, 48, 96, 120, 144, 168, 192, 240, 288, 336, 384, 432, 480, 552, 624, 696, 768, 840, 1008, 1176, 1344 hr post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and sc and iv cohorts: day 1 pre-dose and 1, 2, 4, 8 hours (hr) post-dose; 24, 48, 96, 120, 144, 168, 192, 240, 288, 336, 384, 432, 480, 552, 624, 696, 768, 840, 1008, 1176, 1344 hr post-dose 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) and Number of Participants Who Have Treatment-emergent ADA
Pharmacokinetic Parameter Area Under the Concentration Curve (AUC)
Pharmacokinetic Parameter Elimination Half-life (T1/2)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: DS-2325a SCExperimental Treatment1 Intervention
Participants who will be randomized to receive DS-2325a as a fixed dose subcutaneous (SC) injection (starting dose 30 mg).
Group II: DS-2325a IVExperimental Treatment1 Intervention
Participants who will be randomized to receive DS-2325a as a fixed dose intravenous (IV) infusion (starting dose 100 mg).
Group III: Placebo IVPlacebo Group1 Intervention
Participants who will be randomized to receive placebo as an intravenous infusion.
Group IV: Placebo SCPlacebo Group1 Intervention
Participants who will be randomized to receive placebo as a subcutaneous (SC) injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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 Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,856 Total Patients Enrolled
2 Trials studying Netherton Syndrome
33 Patients Enrolled for Netherton Syndrome
Daiichi SankyoLead Sponsor
418 Previous Clinical Trials
468,503 Total Patients Enrolled
2 Trials studying Netherton Syndrome
33 Patients Enrolled for Netherton Syndrome
Clinical DirectorStudy DirectorDaiichi Sankyo
18 Previous Clinical Trials
4,732 Total Patients Enrolled
1 Trials studying Netherton Syndrome
24 Patients Enrolled for Netherton Syndrome
~19 spots leftby Dec 2025
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