A Randomized, Double-blind, Single-center Phase I/IIa Study of XTYW007 Tablets in Subjects.

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXi'an Xintong Pharmaceutical Research Co.,Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Test drug XTYW007 capsules and placebo,Single dose group
  • Test drug XTYW007 capsules and placebo,Food Impact Group
  • Test drug XTYW007 capsules and placebo,Multiple dosing group

Treatment groups

94 Participants
are divided into 3 treatment groups