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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: Test drug XT1061 capsules and placebo,Single dose group; Drug: Test drug XT1061 capsules and placebo，Multiple dosing group; Drug: Test drug XT1061 capsules and placebo，Food Impact Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ding Yanhua, 硕士; Phone Number: 18743062721; Email: 1023307193@qq.com

Study Locations

• China
  • Changchun
    • Jilin, Changchun, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Ding Yanhua, master; Phone Number: 18743062721; Email: 1023307193@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose group; Single doses of 12.5mg (Group 1), 25mg (Group 2), 37.5mg (Group 3), 62.5mg (Group 4, Group A), 125mg (Group 5), 250mg (Group 6), alternative groups (Groups 7-10, 400-800mg).	Drug: Test drug XT1061 capsules and placebo,Single dose group; Eight people took capsules of the test drug XT1061 and two people took a placebo.
Experimental: Multiple dosing group; Multiple administrations of 125mg, 250mg (groups 11, 12) Select one or both groups.	Drug: Test drug XT1061 capsules and placebo，Multiple dosing group; D1-D7 were administered under fasting conditions for 7 consecutive days, of which D1-D6 were administered BID and D7 was administered once in the morning under fasting conditions only.Eight people took capsules of the test drug XT1061 and two people took a placebo.
Experimental: Food Impact Group; 62.5 mg (i.e., single dose Group 4)	Drug: Test drug XT1061 capsules and placebo，Food Impact Group; Eight people in group A took the test drug XT1061 capsules and two people took placebo, and all eight people in group B took the test drug XT1061 capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related adverse events	Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.	Day 7
Cmax	Cmax	Day 4
Tmax	Tmax	Day 4
t1/2	t1/2	Day 4
AUC	AUC	Day 4
CL/F	CL/F	Day 4
Vz/F	Vz/F	Day 4
CLr/F	CLr/F	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ae0-72 h	Ae0-72 h	Day 4
Fe0-72 h	Fe0-72 h	Day 4
bioavailability	geometric mean value ratio	Day 4

Collaborators and Investigators

• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: XT1061-2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No