A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE I STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF THN391 IN HEALTHY SUBJECTS - THN391 first-in-human SAD and MAD study

Therini Bio0 个研究点目标入组 96 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

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•1. Willing and able to sign the ICF.
•2. Male or female subjects aged 18 to 55 years old, inclusive, at screening.
•3. Subjects of good physical and mental health on the basis of medical history,
•physical examination, clinical laboratory, ECG, and vital signs, as judged by
•the Investigator.
•4. Subjects with a weight between 50.0 kg and 110.0 kg (inclusive) and a body
•mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening.
•5. At screening, female subjects must not be pregnant or lactating, or of
•nonchildbearing potential (either surgically sterilized or physiologically
•incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea
•duration of 12 consecutive months]); nonpregnancy will be confirmed for all
•females by a negative serum pregnancy test at screening, at each admission, and
•follow-up.
•Further criteria apply

•1. Subjects who, in the opinion of the Investigator, are or have experienced
•significant and/or acute illness within 5 days prior to screening or (first)
•admission to the clinical research center.
•2. Subjects who, in the opinion of the Investigator, are experiencing clinical
•signs and/or symptoms of an infection, including sinusitis, cellulitis,
•bronchitis, or urinary tract infections, within 5 days prior to screening or
•(first) admission to the clinical research center.
•3. Subjects with a history of coagulation or clotting disorders, either genetic
•or acquired, including but not limited to: deep vein thromboses (with or
•without pulmonary embolism), Protein C, S, or antithrombin deficiencies, Factor
•V or prothrombin mutations, von Willebrand disease, hemophilia,
•antiphospholipid syndrome, or disseminated intravascular coagulation.
•4. Subjects with a positive screen for hepatitis B surface antigen (HBsAg),
•hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and
•2 antibodies.
•5. Subject who are current smoker or use nicotine products within 3 months
•prior to screening.
•Further criteria apply

发起方

Therini Bio