DS-2325a for Netherton Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Worldwide Clinical Trials, San Antonio, TX
Netherton Syndrome
DS-2325a - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS. DS-2325a, a specific and potent inhibitor of kallikrein 5, is expected to treat NS by replacing a defective gene.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Netherton Syndrome

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 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

Day 1
Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Number of Participants Who Have Treatment-emergent ADA
Day 1
Pharmacokinetic Parameter Area Under the Concentration Curve (AUC)
Pharmacokinetic Parameter Elimination Half-life (T1/2)
Pharmacokinetic Parameter Elimination Rate Constant Associated With the Terminal Phase (Kel)
Pharmacokinetic Parameter Last Measurable Time (Tlast)
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Day 57
Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325a

Trial Safety

Safety Progress

1 of 3

Other trials for Netherton Syndrome

Trial Design

4 Treatment Groups

DS-2325a IV
1 of 4
DS-2325a SC
1 of 4
Placebo SC
1 of 4
Placebo IV
1 of 4
Experimental Treatment
Non-Treatment Group

64 Total Participants · 4 Treatment Groups

Primary Treatment: DS-2325a · Has Placebo Group · Phase 1

DS-2325a IV
Drug
Experimental Group · 1 Intervention: DS-2325a · Intervention Types: Drug
DS-2325a SC
Drug
Experimental Group · 1 Intervention: DS-2325a · Intervention Types: Drug
Placebo SC
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo IV
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

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Worldwide Clinical Trials · San Antonio, TX
Photo of San Antonio 1Photo of San Antonio 2Photo of San Antonio 3
2011First Recorded Clinical Trial
1 TrialsResearching Netherton Syndrome
43 CompletedClinical Trials

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
348 Previous Clinical Trials
336,280 Total Patients Enrolled
Clinical DirectorStudy DirectorDaiichi Sankyo, Inc.
14 Previous Clinical Trials
3,800 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must give written informed consent to participate in the study.
You are 18 to 45 years of age (inclusive), and you are either a healthy man or a healthy woman.
You are a woman of childbearing potential who is willing to use effective contraception during the study treatment period and for 3 months after the last dose of study treatment
You are in good health as determined by Screening medical history, physical examination, vital signs, ECGs, serum chemistry, hematology, virology, and urinalysis performed at Screening and on Day -1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.