Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.
Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial;
They are able to complete the study according to the requirements of the trial protocol;
Subjects (including partners) are willing to have no pregnancy plan and voluntarily use effective contraceptive measures within 6 months from screening to the last dose of study drug;
Male and female subjects between the ages of 18 and 65 (including borderline values);
Individuals with allergic constitution (allergic to multiple drugs and foods) or intolerance to β-blockers;
History of thyroid-related diseases and/or thyroid function abnormalities during the screening phase that are clinically significant;
Individuals who smoked more than 5 cigarettes per day in the 3 months prior to the trial;
History of drug abuse and/or alcoholism (consuming 14 units of alcohol per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine);
Sequential
Test drug XTYW007 capsules and placebo,Single dose group
DrugEach group consists of 8 people, with 6 receiving the trial drug XTYW007 and 2 receiving a placebo. The sentinel method is used for enrollment, meaning that the first 2 subjects (one male and one female, both receiving the trial drug) are enrolled and observed for 96 hours (after the Day 5 tolerance assessment). If there are no intolerable reactions, the remaining 6 subjects are enrolled and randomly assigned to receive the trial drug or placebo in a 2:1 ratio.
Test drug XTYW007 capsules and placebo,Food Impact Group
DrugA two-period crossover administration was used, with a 14-day washout period. In Group A, 8 subjects received the drug on D1 under fasting conditions in the first period, and on D15 under fed conditions in the second period. In Group B, 6 subjects taking the investigational drug received it on D1 under fed conditions in the first period, and on D15 under fasting conditions in the second period.
Test drug XTYW007 capsules and placebo,Multiple dosing group
DrugEach group consists of 8 subjects, with 6 receiving the investigational drug XTYW007 and 2 receiving a placebo. A sentinel dosing approach is used, where 2 subjects (one male and one female) are first enrolled and administered the investigational drug. After 96 hours of observation (tolerance evaluation on Day 5), if no intolerable issues occur, the remaining 6 subjects are enrolled and randomized 2:1 to receive the investigational drug or placebo. In the multiple-dose group, the drug is administered once every morning on an empty stomach (QD) for 14 consecutive days.
Treatment-related adverse events
Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.
Cmax
Cmax
Tmax
Tmax
t1/2
t1/2
Ae0-72 h
Ae0-72 h
Fe0-72 h
Fe0-72 h
Blood lipids
TC , TG , LDL-C, HDL-C, Apo A1, Apo B, Lp(a)
Thyroid function
TSH, TT4, TT3, FT4, FT3
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
