NCT05583669

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

A Phase 1, Subject- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study for DS-2325a will evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of DS-2325a in healthy participants. DS-2325a will be evaluated after subcutaneous (SC) injections.

Conditions

• Netherton Syndrome

Interventions

Type	Name	Description
DRUG	DS-2325a	Subcutaneous injection (starting dose 300 mg)
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2022-10-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study