A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety, tolerability, and pharmacokinetics of G201-Na capsules in a single dose in healthy adult male subjects in China, Phase Ia clinical study to evaluate the safety, tolerability and pharmacokinetics of G201-Na capsules in a single dose escalation in healthy Chinese adult male subjects

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: 25mg group:4 volunteers were given 25 mg of the test drug;75mg group:Si Xvolunteers were given 75 mg of test drug and two volunteers were given placebo;150mg group:Eight volunteers were given 150 mg of test drug and two volunteers were given placebo;300mg group:Eight volunteers were given 300 mg of test drug and two volunteers were given placebo;600mg group:Eight volunteers were given 600 mg of test drug and two volunteers were given placebo;900mg group:Eight volunteers were given 900 mg of test drug and two volunteers were given placebo;1200mg group:6 volunteers were given 1200 mg of test drug and two volunteers were given placebo; CONDITION: Prostate Cancer PRIMARY OUTCOME: Vital signs;Physical Examination;Blood Count;Blood Biochemistry;12‐lead electrocardiogram;Adverse Events;Cmax;Tmax;AUC0‐t;AUC0‐8;t1/2;?z;Luteinizing hormone, LH;follicle stimulating hormone, FSH;testosterone; SECONDARY OUTCOME: Urine Routine;Convenient routine;Blood Transfusion IV; INCLUSION CRITERIA: 1) Age = 18 years and = 65 years, male; 2) Weight = 50.0 kg with a body mass inde X(BMI) between 19 26 kg/m2, including thresholds; 3) The subjects had no birth plan and voluntarily took medically approved contraceptive measures within 3 months after the screening visit, including but not limited to: correct use of male condoms, abstinence, and no sperm donation plan; Or the spouse uses hormonal contraceptives, intrauterine device or intrauterine hormone release system, or either party has undergone sterilization; 4) The subject voluntarily signs a written informed consent form.
Epistemonikos ID: 84fae0e0a560016ed8ef4d975c8eeecf99785b11
First added on: Feb 20, 2024