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Активно (без набиране) Фаза 1 NCT07078695

A Trial of SHR-1139 in Healthy Volunteers

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Psoriasis

Спонсор: Atridia Pty Ltd.

Налично на: БГ
Обобщение
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Кой може да участва
Inclusion Criteria: 1. Healthy white participants. 2. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study. 3. Male aged between 18 to 55 years of age (inclusive) 4. Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 5. Men and WOCBP must agree to take highly effective contraceptive methods Exclusion Criteria: 1. History or evidence of clinically significant disorders. 2. Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or any component of it. 3. Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening. 4. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol. 5. Positive pregnancy test at screening or D-1/check-in. 6. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Места на провеждане 1
Австралия (1)
Linear
Perth , Western Australia
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
55 Years
Здрави доброволци
Не
Начална дата
19.08.2025
Крайна дата
30.09.2026
Регистрационен номер
NCT07078695
Източник
anzctr
Запитване за медицински туризъм

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