A Phase I, Randomized, Double-blind, Placebo-controlled, SingleAscending Dose and Multiple Ascending Dose Clinical Study to Assess theSafety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy AdultVolunteers. - Clinexel-GBL-003

Godavari Biorefineries Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•1.Should be healthy adult volunteer, with a BMI 18-30 kg/m2 (both inclusive).
•2.Volunteer is able to read the volunteer information sheet, to understand information about the study and willing to sign the informed consent voluntarily.
•3.Healthy as determined by pre-study medical history, physical examination, vital signs, haematology, chemistry parameters, pulse
•rate and/or blood pressure, and ECG within the reference range, or showing no clinically relevant deviations, as judged by the Investigator.
•4. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis Cvirus antibody (anti-HCV) and human immunodeficiency virus(HIV)-l and HIV -2 antibody at screening.
•5.Clinical laboratory test results clinically acceptable at screening and admission.

•1.The volunteer has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests,as evaluated by the Investigator
•2.The volunteer has had a clinically significant illness or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs, within 30 days of Check-in for the study.
•3.The volunteer has a clinically relevant history or presence of significant respiratory, neurological, hepatic, renal, endocrine,
•cardiovascular, neurological, gastrointestinal, pulmonary, haematological, psychiatric, musculoskeletal, genitourinary,
•immunological, dermatological, endocrine, connective tissue,
•lymphatic or metabolic disease or disorders.
•4.The volunteer has a significant infection or known inflammatory process on screening or admission
•5.The volunteer has acute gastrointestinal symptoms (e.g., nausea,
•vomiting, diarrhoea, heartburn) at the time of screening or admission.
•6.If female:
•a. Pregnancy or breast-feeding.
•b. Woman of childbearing potential not using an accepted effective contraceptive method or using oral contraceptives.
•a. Not using an accepted effective method of contraception

发起方

Godavari Biorefineries Ltd