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

Overseen By Contact for Clinical Trial Information

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Director

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

Inclusion Criteria

Women of non-childbearing potential must be either surgically sterile or in menopausal state confirmed as follows: 1 year of spontaneous amenorrhea without an alternative medical cause and a serum follicle stimulating hormone (FSH) level ≥40 mIU/mL.

Women cannot donate eggs and men cannot donate sperm during the study and for at least 90 days after the last treatment dose.

Aged 18 to 50 years of age (inclusive) at the time of signing informed consent.

Exclusion Criteria

History, or presence in the average of triplicate ECGs at Screening and Admission (Day -2).

Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range, if considered clinically significant by the Investigator at Screening or Admission (Day -2).

Creatinine clearance (CrCl) <80 mL/mina t Screening.

Treatment Details

Interventions

• DS-2325a (Kallikrein 5 Inhibitor)
• Placebo (Drug)

Participant Groups

Group I: Placebo SC Experimental Treatment 1 Intervention

Participants who will be randomized to receive placebo as a subcutaneous (SC) injection.

Group II: DS-2325a SC Experimental Treatment 1 Intervention

Participants who will be randomized to receive DS-2325a as a fixed dose subcutaneous (SC) injection (starting dose 300 mg).

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University