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

Sponsor
Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Study ID
NCT07407634
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Test drug XTYW007 capsules and placebo,Single dose group — DRUG
    Each 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 — DRUG
    A 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 — DRUG
    Each 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.

Study Details

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.

Key Dates

First listed
Feb 12, 2026
Start date
Mar 25, 2026
Status verified
Feb 2026
Primary completion
Feb 26, 2027
Completion
May 27, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single dose group
    Group 1 (0.2 mg), Group 2 (0.6 mg), Group 3 (1.5 mg), Group 4 (3 mg), Group 5, Group A (6 mg), Group 6 (10 mg), Group 7 (15 mg), optional dose Group 8 (20 mg)
  • Experimental: Food Impact Group
    Group 5, Subgroup A（6mg）, Group 5, Subgroup B（ 6 mg）
  • Experimental: Multiple dosing group
    Group 9 (1.5 mg), Group 10 (6 mg), Group 11 (15 mg)

Primary Outcome Measure

Treatment-related adverse events [ Time Frame: Days 1-11 of administration ]

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