Sağlıklı Gönüllülerde Tek Artan Deri Altı ve Damar İçi DS-2325a Dozlarının Güvenliliği ve Farmakokinetiğini Değerlendiren Bir Çalışma

Sade dilde özet

Bu çalışma, DS-2325a adlı ilacın tek ve giderek artan dozlarının deri altı ve damar içi uygulanmasının güvenliliğini ve vücuttaki davranışını (farmakokinetiğini) değerlendirmektedir. Çalışmaya, 18-45 yaş arası sağlıklı erkek ve kadın gönüllüler katılmış, bir kısmına ilaç yerine plasebo verilmiştir. 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, DS-2325a, Placebo, Placebo

Başlangıç

20.06.2022

Tahmini bitiş

26.01.2023

Ülkeler

United States

İlgili genler

Merkezler

• San Antonio, United States

Uygunluk kriterleri

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

Inclusion Criteria:

* Participants must give written informed consent to participation in the study prior to Screening
* Healthy men and women 18 to 45 years of age (inclusive), with a BMI of 18 kg/m2 to 30 kg/m\^2 (inclusive) at Screening
* All women must have a negative serum pregnancy test at Screening and all women of childbearing potential must have a negative urine pregnancy test on Day -1
* Women must not be lactating during the study treatment period and for 3 months after the last dose of study treatment
* Women of childbearing potential must practice effective contraception during the study treatment period and for 3 months after the last dose of study treatment. They must agree to use 2 different means of nonhormonal contraceptive methods
* Women of non-childbearing potential must be either surgically sterile (ie, bilateral tubal ligation at least 3 months prior to dosing) or in menopausal state confirmed as follows: 1 year of spontaneous amenorrhea without an alternative medical cause and a serum FSH level ≥40 mIU/mL
* Men must agree to use contraception (condom with spermicide) during the study treatment period and for at least 3 months after the last dose of study treatment or be surgically sterile (vasectomy at least 3 months prior to dosing)
* Women should not donate eggs and men should not donate sperm during the study treatment period and for at least 3 months after the last dose of study treatment
* Participants must be in good health as determined by Screening medical history, physical examination, vital signs, ECGs, serum chemistry, hematology, virology, and urinalysis performed at Screening and on Day -1

Exclusion Criteria:

* History or current chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), or heavy smoking of \>10 pack years
* Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
* Participants who have received a transfusion or any blood products within the last year prior to dosing
* Participants who have made any blood donation or have had a loss of blood of ≥500 mL within 56 days prior to the dose of study drug
* Participants who consume more than 21 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years.
* Participants with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and/or Day -1.