← Back to Search

Kallikrein 5 Inhibitor

DS-2325a SC for Netherton Syndrome

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
Awards & highlights

Study Summary

This trial will test a new medicine that could help people with Netherton Syndrome, a rare and serious disease with no current treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Any Treatment-emergent Adverse Events Following Administration of DS-2325a
Secondary outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,341 Total Patients Enrolled
2 Trials studying Netherton Syndrome
76 Patients Enrolled for Netherton Syndrome
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
415,273 Total Patients Enrolled
2 Trials studying Netherton Syndrome
76 Patients Enrolled for Netherton Syndrome
Clinical DirectorStudy DirectorDaiichi Sankyo
17 Previous Clinical Trials
4,471 Total Patients Enrolled
1 Trials studying Netherton Syndrome
64 Patients Enrolled for Netherton Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what demographic does the eligibility for this trial extend?

"To be eligible for this research, enrollees must have Netherton Syndrome and fall between 18 to 50 years old. The current goal is 24 participants in total."

Answered by AI

Are there presently any opportunities for participants to enroll in this research initiative?

"Indeed, according to clinicaltrials.gov, this trial is actively looking for participants and was first posted on November 8th 2022. It has been recently updated and requires 24 individuals across 1 site to be enrolled."

Answered by AI

What is the greatest quantity of participants enrolled in this research trial?

"Affirmative. Clinicaltrials.gov reveals that this research is still recruiting participants, with a launch date of November 8th 2022 and the most recent update being on the same day. 24 patients are needed at one medical site to complete the trial's objective."

Answered by AI

Does this research trial accept individuals over the age of 45?

"The eligibility criteria stipulate that participants must be between the age of 18 and 50 in order to take part."

Answered by AI

Has the FDA approved DS-2325a for subcutaneous delivery?

"Limited evidence of DS-2325a SC's safety and efficacy places its risk score at 1 on our assessment scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects
2022. "A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05583669.
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top