A non-randomized, open-label, non-controlled, adaptive, multiple-dose study to investigate the safety, tolerability, and pharmacokinetics of zosurabalpin following intravenous administration in healthy participants

F. Hoffmann-La Roche Ltd0 个研究点目标入组 45 人开始时间: 2023年9月29日最近更新: 2023年12月19日

试验速览

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•1. Able and willing to provide written informed consent and to comply with the study protocol.
•2. Participants must weigh at least 50 kilogram (kg) and must have a body mass index (BMI) within the range of 18 to 32 kg per square meter (kg/m2) (inclusive) at screening.
•3. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, coagulation, and urinalysis.
•4. Participants must agree to remain abstinent or at least one highly effective contraceptive method.

•1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis.
•2. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study.
•3. History of malignancy.
•4. Use of glucocorticoids and other immunosuppressive medications within 30 days (or within 5 times the elimination half-life, whichever is longer) prior to Day 1 and until follow-up.
•5. Are currently enrolled in, have participated in, or plan to participate in this or any other clinical study involving an investigational medicinal product (IMP) or medical device study from within the 30 days directly preceding screening or within 5 times the elimination half-life, if known (whichever is longer), until the completion of the follow-up visit.
•6. Participation in four or more interventional clinical studies within 12 months prior to enrollment (Day 1).
•7. Donation of blood or blood products for transfusion over 100 mL in the last 30 days or 500 mL in the last 3 months or had significant blood loss within 3 months prior to the first study treatment administration.
•8. Participants with insufficient venous access.
•9. History of hypersensitivity to any of the excipients in the formulation of zosurabalpin.

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