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Kallikrein 5 Inhibitor

DS-2325a for Netherton Syndrome

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
Awards & highlights

Study Summary

This trial is testing a new drug, DS-2325a, to see if it can treat Netherton syndrome, a rare disease with no current cure.

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

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) 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

Find a Location

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
415,233 Total Patients Enrolled
2 Trials studying Netherton Syndrome
36 Patients Enrolled for Netherton Syndrome
Daiichi SankyoLead Sponsor
392 Previous Clinical Trials
411,301 Total Patients Enrolled
2 Trials studying Netherton Syndrome
36 Patients Enrolled for Netherton Syndrome
Clinical DirectorStudy DirectorDaiichi Sankyo
17 Previous Clinical Trials
4,431 Total Patients Enrolled
1 Trials studying Netherton Syndrome
24 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.

Does this research protocol encompass participants aged 35 and older?

"Participants that meet the criteria for this research must be between 18 and 45 years old. For younger or older patients, there are separate trials with 1 study suitable for minors and 3 tailored to those over 65."

Answered by AI

Am I eligible to partake in this research project?

"This clinical trial is recruiting 64 individuals with Netherton Syndrome aged between 18 and 45. It is imperative that these patients meet the following prerequisites: written consent to take part in this study, a healthy BMI of 18-30 kg/m^2 at screening, non-pregnant female participants must have negative pregnancy tests both on day -1 and during treatment period (and agree to use two separate forms of contraception) males should either practice safe sex or be surgically sterile; both genders are not allowed to donate sperm/eggs for 3 months after treatment ends; pass medical examinations held by physical examination, vital signs, ECGs"

Answered by AI

What is the total sample size of this medical experiment?

"Indeed, clinicaltrials.gov indicates that the trial is currently recruiting patients. The project was first posted on June 20th 2022 and has since been updated as of September 27th 2022. 64 individuals are being recruited from a single facility for this study."

Answered by AI

Are there any vacant slots left for this research program?

"Affirmative, the information located on clinicaltrials.gov highlights that recruitment for this medical trial is ongoing. It was initially posted on June 20th 2022 and most recently updated on September 27th 2022 with a need to recruit 64 patients from one site."

Answered by AI

Has DS-2325a been sanctioned by the Food and Drug Administration?

"The limited data available on DS-2325a's safety and efficacy led our team to rate its risk level as a 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects
2022. "A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388903.
~23 spots leftby Apr 2025
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