Sağlıklı Kişilerde Deri Altına Uygulanan Artan Çoklu DS-2325a Dozlarının Güvenliğini ve Farmakokinetiğini Değerlendiren Çalışma

Sade dilde özet

Bu çalışma, DS-2325a adlı deneysel ilacın deri altına artan dozlarda uygulanmasının güvenliğini ve vücutta nasıl işlendiğini (farmakokinetiğini) sağlıklı gönüllülerde değerlendirmektedir; karşılaştırma için plasebo (Placebo) da kullanılmaktadır. Çalışmaya 18 ile 50 yaş arası, sağlıklı ve belirlenen vücut kitle indeksi ölçütlerini karşılayan gönüllüler katılabilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Daiichi Sankyo

Müdahale

DS-2325a, Placebo

Başlangıç

08.11.2022

Tahmini bitiş

11.05.2023

Ülkeler

United States

İlgili genler

Merkezler

• Miami, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
* Must be willing and able to comply with all study requirements.
* Healthy males or non-pregnant, non-lactating healthy females.
* Aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
* BMI of 18.0 kg/m\^2 to 30.0 kg/m\^2 (inclusive) as measured at Screening.
* Women of childbearing potential who are sexually active with a male partner must practice effective contraception during the study treatment period and for 90 days after last IMP administration. They must agree to use 2 different means of nonhormonal contraceptive methods.
* 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.
* Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days after last IMP administration.
* Women should not donate eggs and men should not donate sperm during the study treatment period and for at least 90 days after last IMP administration.
* All female participants must have a negative serum pregnancy test at Screening and Admission (Day -2).

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, metabolic, endocrine, immunologic, infectious, dermatologic, neurologic, oncologic, psychological, psychiatric, ophthalmologic, or gastrointestinal disease (except cholecystectomy), as judged by the Investigator.
* History or presence of chronic lung or respiratory disease, including clinically significant asthma (as judged by the Investigator) and chronic obstructive pulmonary disease (COPD).
* 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.
* History or presence of any other clinically significant condition, including laboratory abnormality, that in the opinion of the Investigator, would jeopardize the safety of the participant, obtaining informed consent, compliance to the study procedures, or the validity of the study results.