NCT05388903 is a Phase 1 clinical trial of DS-2325a in Netherton Syndrome, sponsored by Daiichi Sankyo.

Who is sponsoring NCT05388903?

NCT05388903 is sponsored by Daiichi Sankyo.

What drugs are being tested in NCT05388903?

Interventions in NCT05388903: DS-2325a, DS-2325a, Placebo, Placebo.

What condition does NCT05388903 study?

NCT05388903 studies Netherton Syndrome.

Is NCT05388903 still recruiting?

NCT05388903 is currently completed. Last updated 6 March 2023.

Last reviewed 2023-03-06 · How we verify

NCT05388903

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 6 March 2023

What this trial tests

Phase 1 trial testing DS-2325a in Netherton Syndrome in 64 participants. Completed in 26 January 2023.

Timeline

20 June 2022

Primary endpoint
26 January 2023

26 January 2023

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	20 June 2022
Primary completion	26 January 2023
Estimated completion	26 January 2023
Sites	1 location across United States

Drugs / interventions tested

DS-2325a — full drug profile →
DS-2325a — full drug profile →
Placebo
Placebo

Conditions studied

Netherton Syndrome — all drugs for Netherton Syndrome →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

Adults 18 to 45, any sex, with Netherton Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

MEN1 mutations mediate clinical resistance to menin inhibition.
Perner F, Stein EM, Wenge DV, Singh S, et al · · 2023 · cited 192× · PMID 36922589 · DOI 10.1038/s41586-023-05755-9

Verify or expand the search:

Other trials of DS-2325a

Trials testing the same drug.

NCT05979831 — A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherto · Phase 1, PHASE2 · terminated
NCT05583669 — A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjec · Phase 1 · completed

Other recruiting trials for Netherton Syndrome

Currently open trials in the same condition.

NCT06137157 — Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome · Phase 1 · recruiting
NCT05789056 — Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome · Phase 2, PHASE3 · recruiting
NCT05521438 — Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome · Phase 2, PHASE3 · active not recruiting

Other Daiichi Sankyo trials

Trials by the same sponsor.

NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero · active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05388903 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 6 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05388903.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing