Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG121 Tablets (NCT05576584) | Clinical Trial Compass
UnknownPhase 1
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG121 Tablets
China114 participantsStarted 2022-07-19
Plain-language summary
This phase I clinical study is a phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and food effects of single / continuous administration in Chinese adult healthy subjects
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subjects must give informed consent to the test before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign a written informed consent;
✓. Able to complete the research according to the requirements of the test scheme;
✓. Chinese male and female subjects aged between 18 and 55 years old (both inclusive).
✓. The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is within the range of 18-28 kg / m2 (including the critical value);
✓. Effective contraceptive measures can be taken within 6 months from the start of screening to the last administration of the trial drug, and sperm and eggs donation shall be avoided during this period. See Appendix 5 for specific contraceptive measures;
✓. At the time of screening, there was no history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities with clinical significance;
✓. At the time of screening, the results of vital signs, physical examination, laboratory examination, electrocardiogram, abdominal color ultrasound (liver, gallbladder, spleen, pancreas, double kidneys) and chest X-ray (positive position) examination were normal or abnormal but judged by the investigator to have no clinical significance.
Exclusion criteria
✕. Hospitalization within 30 days before the trial administration, or surgical operation within 6 months before the trial administration, or the presence of transplanted organs in the body, or any medical condition that is not suitable for participating in the trial according to the judgment of the investigator;
✕. Those who have participated in other intervention clinical trials and used clinical study drugs within 3 months before the trial administration or plan to participate in other clinical studies at the same time during the study (if the subjects withdraw from the study before treatment, that is, they are not randomized or treated, they can be included in the study);
✕. Have been vaccinated with live vaccine within 3 months before the trial administration, or need to be vaccinated during the study period;
✕. Clinically significant drug allergy history or specific allergic disease history (asthma, urticaria) or known allergy to the test drug or its excipients;
✕. Blood donation or massive blood loss (\> 450 ml) or use of blood products or blood transfusion within three months before screening;
✕. Those who smoked more than 5 cigarettes per day on average 3 months before the trial;
✕. The subjects had a history of alcoholism within 12 months before the screening (drinking 14 units of alcohol every week: 1 unit = 285 ml of beer, 25 ml of liquor, or 100 ml of wine), or the subjects could not use any alcohol containing products within 72 hours before the test administration and during the whole test, or the subjects were positive in the alcohol breath test during the screening period;
✕. Those with positive urine drug screening (morphine, marijuana) or drug abuse history;