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Single ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS2001a in healthy participants

Phase 1 Study of DS2001a

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial_jp@daiichisankyo.com

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial_jp@daiichisankyo.com

Pending

April. 03, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Healthy participants (males or females)
2. Age: 18 to 45 years at the time the ICF is signed.
3. A body mass index (BMI) >= 18.5 and < 25.0 kg/m^2 at screening test.

1. Having a history of serious disease attributed to central nervous, cardiovascular, respiratory, blood and hematopoietic, gastrointestinal, hepatic and renal, thyroid, pituitary gland, or adrenal disorder, and participation in the study potentially endangering the participant, as judged by the investigator or sub-investigator.
2. Having clinically significant participant-reported symptoms/findings (e.g. headache, dizziness), objective symptoms/findings (e.g. decreased blood pressure), abnormalities on an ECG, or laboratory values outside the study site's reference range at screening, as observed by the investigator or sub-investigator. (However, the participant will not be excluded if these symptoms/findings would not affect participation in the study, as judged by the investigator or sub-investigator.)
3. Having a history of hypersensitivity to drugs or other substances or being idiosyncratic (e.g. Having penicillin allergy)
4. Having alcohol or drug dependencies
5. Having superficial skin infection within 7 days before the screening test.
6. Having a history of recurrent oral herpes or recurrent genital herpes.
7. Having history of histoplasmosis, listeriosis, coccidioidomycosis, thrush, pneumocystis pneumonia, aspergillosis, or other invasive opportunistic infections, parasitic infections, or pulmonary tuberculosis
8. Having a history of immunodeficiency disorders or being immunocompromised due to such conditions.

Both

Healthy participants

Single ascending dose of DS2001a or Placebo.

Safety and tolerability endpoints:
Incidence of adverse events, laboratory data, body weight, vital signs measurements (blood pressure, pulse rate, axillary body temperature) and standard 12-lead electrocardiogram (ECG)

PK:
Plasma DS2001a concentration and pharmacokinetic parameters

ADA:
Plasma ADA prevalence and incidence

No

none