Evaluating the safety and tolerability of XT1061 in healthy individuals

Randomized, Double-blind, Single Center Phase Ia Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects

This study is testing a new drug called XT1061 in healthy people to see if it's safe and how well their bodies handle it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. (Academic / other)
• Locations: 1 site (Jilin, Changchun)
• Trial ID: NCT06280534 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of the drug XT1061 in healthy subjects. Participants will receive either single or multiple doses of XT1061 capsules, with some groups also evaluating the impact of food on drug absorption. The study aims to gather data on how the drug is metabolized and its overall safety profile. It is conducted at a single center, ensuring controlled conditions for the evaluation.

Who should consider this trial

Good fit: Ideal candidates are healthy male and female adults aged 18 to 65 who meet specific weight and BMI criteria.

Not a fit: Patients with significant allergies, smokers, or those with health issues that could affect the study outcomes may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of XT1061's safety and tolerability, paving the way for its use in treating chronic hepatitis B.

How similar studies have performed: While this study focuses on a specific drug, similar studies evaluating the safety and pharmacokinetics of new treatments have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial;
2. They are able to complete the study according to the requirements of the trial protocol;
3. 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;
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 clinical significance.

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 of beer, or 25 mL of spirits, or 100 mL of wine);
4. Blood donation or significant blood loss (\> 450 mL) within three months prior to taking study drug;
5. taking any prescription drug, over-the-counter drug, any vitamin product, herbal remedy, or alcohol within 14 days prior to taking study drug;
6. have taken a special diet (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., rich in flavonoids or citrus glycosides), or have had strenuous physical activity, 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 within three months prior to taking the study drug;
9. have dysphagia or a history of any gastrointestinal disorder that interferes with the absorption of the drug within 6 months prior to the trial;
10. have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, 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 a positive serum pregnancy result during the screening period or during the course of the trial;
13. Abnormal and clinically significant clinical laboratory tests, or other clinical findings within the 12 months prior to screening that indicate clinically significant disease 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 C Antibody/Hepatitis C Core Antigen, HIV Antigen/Antibody, or Syphilis Spirochete Antibody;
15. Acute illness or concomitant medication from the screening phase until study drug administration;
16. ingestion of chocolate, any caffeinated or xanthine-containing food or beverage 24 hours prior to study drug administration;
17. A positive urine drug screen or a history of substance abuse or drug use within the past 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. Or those who did not agree to comply with the drinking arrangements and postural restrictions during the trial;
20. Subjects who, in the opinion of the investigator, have other factors that make them unsuitable for participation in this trial.

Where this trial is running

Jilin, Changchun

• The First Hospital of Jilin University — Jilin, Changchun, China (Recruiting)

Study contacts

• Study coordinator: Ding Yanhua, 硕士

Conditions Chronic Hepatitis b