Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects

Last updated: February 22, 2024
Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis B

Treatment

Test drug XT1061 capsules and placebo,Food Impact Group

Test drug XT1061 capsules and placebo,Single dose group

Test drug XT1061 capsules and placebo,Multiple dosing group

Clinical Study ID

NCT06280534
XT1061-2022-01
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily sign the informed consent before the trial, and fully understandthe content, process and possible adverse effects of the trial;
  2. They are able to complete the study according to the requirements of the trialprotocol;
  3. Subjects (including partners) are willing to have no pregnancy plan and voluntarilyuse effective contraceptive measures within 6 months from screening to the last doseof study drug;
  4. Male and female subjects between the ages of 18 and 65 (including borderline values);
  5. Male subjects weighing not less than 50 kg and female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI within the range of 18-28 kg/m2 (including the threshold value);
  6. Physical examination and vital signs are normal or abnormal without clinicalsignificance.

Exclusion

Exclusion Criteria:

  1. Allergy (multiple drug and food allergies);
  2. Those who smoked more than 5 cigarettes per day in the 3 months prior to the test;
  3. History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL ofbeer, or 25 mL of spirits, or 100 mL of wine);
  4. Blood donation or significant blood loss (> 450 mL) within three months prior totaking study drug;
  5. taking any prescription drug, over-the-counter drug, any vitamin product, herbalremedy, or alcohol within 14 days prior to taking study drug;
  6. have taken a special diet (e.g., grapefruit, mango, dragon fruit, grape juice, orangejuice, etc., rich in flavonoids or citrus glycosides), or have had strenuous physicalactivity, or any other factor that affects the absorption, distribution, metabolism,or excretion of the drug within 2 weeks prior to administration of the study drug;
  7. Those who have recently made significant changes in their dietary or exercise habits;
  8. have taken the study drug, or participated in a clinical trial of the drug withinthree months prior to taking the study drug;
  9. have dysphagia or a history of any gastrointestinal disorder that interferes with theabsorption of the drug within 6 months prior to the trial;
  10. have any condition that increases the risk of bleeding, such as hemorrhoids, acutegastritis, or gastroduodenal ulcers
  11. clinically significant ECG abnormalities; QTcF >470ms (QTcF=QT/(RR)^0.33); and
  12. Female subjects who are breastfeeding or recently preparing for pregnancy or have apositive serum pregnancy result during the screening period or during the course ofthe trial;
  13. Abnormal and clinically significant clinical laboratory tests, or other clinicalfindings within the 12 months prior to screening that indicate clinically significantdisease of the following (including, but not limited to, gastrointestinal, renal,hepatic, neurological, hematological, endocrine, oncological, pulmonary,immunological, psychiatric, or cardiovascular disease);
  14. Positive screening for any of the Hepatitis B Surface Antigen, Hepatitis CAntibody/Hepatitis C Core Antigen, HIV Antigen/Antibody, or Syphilis SpirocheteAntibody;
  15. Acute illness or concomitant medication from the screening phase until study drugadministration;
  16. ingestion of chocolate, any caffeinated or xanthine-containing food or beverage 24hours prior to study drug administration;
  17. A positive urine drug screen or a history of substance abuse or drug use within thepast five years;
  18. serum creatinine clearance ≤ 70 mL/min [formula: Ccr: (140 - age) × body weight (kg) / (0.818 × Scr) (μmol/L), female × 0.85].
  19. Those who have special dietary requirements and cannot eat the entire test meal. Orthose who did not agree to comply with the drinking arrangements and posturalrestrictions during the trial;
  20. Subjects who, in the opinion of the investigator, have other factors that make themunsuitable for participation in this trial.

Study Design

Total Participants: 128
Treatment Group(s): 3
Primary Treatment: Test drug XT1061 capsules and placebo,Food Impact Group
Phase: 1
Study Start date:
July 18, 2023
Estimated Completion Date:
March 31, 2024

Study Description

This trial is a randomized, double-blind, dose-escalation, placebo-controlled, single-center clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile and metabolic conversion of XT1061 in healthy subjects with single and multiple administrations, as well as a study of the effect of food on pharmacokinetics.

Connect with a study center

  • The First Hospital of Jilin University

    Jilin, Changchun
    China

    Active - Recruiting

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