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

NCT06280534 | Unknown Phase 1

• 1 other identifier: XT1061-2022-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Ae0-72 h

  Day 4

• Fe0-72 h

  Day 4

• bioavailability

  Day 4

Study Arms (3)

Single dose group

EXPERIMENTAL

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

Multiple dosing group

EXPERIMENTAL

Multiple administrations of 125mg, 250mg (groups 11, 12) Select one or both groups.

Drug: Test drug XT1061 capsules and placebo，Multiple dosing group

Food Impact Group

EXPERIMENTAL

62.5 mg (i.e., single dose Group 4)

Drug: Test drug XT1061 capsules and placebo，Food Impact Group

Interventions

Test drug XT1061 capsules and placebo,Single dose group DRUG

Eight people took capsules of the test drug XT1061 and two people took a placebo.

Single dose group

Test drug XT1061 capsules and placebo，Multiple dosing group DRUG

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.

Multiple dosing group

Test drug XT1061 capsules and placebo，Food Impact Group DRUG

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.

Food Impact Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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);
• Physical examination and vital signs are normal or abnormal without clinical significance.

You may not qualify if:

• Allergy (multiple drug and food allergies);
• Those who smoked more than 5 cigarettes per day in the 3 months prior to the test;
• 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);
• Blood donation or significant blood loss (\> 450 mL) within three months prior to taking study drug;
• taking any prescription drug, over-the-counter drug, any vitamin product, herbal remedy, or alcohol within 14 days prior to taking study drug;
• 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;
• Those who have recently made significant changes in their dietary or exercise habits;
• have taken the study drug, or participated in a clinical trial of the drug within three months prior to taking the study drug;
• have dysphagia or a history of any gastrointestinal disorder that interferes with the absorption of the drug within 6 months prior to the trial;
• have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastroduodenal ulcers
• clinically significant ECG abnormalities; QTcF \>470ms (QTcF=QT/(RR)\^0.33); and
• 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;
• 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);
• Positive screening for any of the Hepatitis B Surface Antigen, Hepatitis C Antibody/Hepatitis C Core Antigen, HIV Antigen/Antibody, or Syphilis Spirochete Antibody;
• Acute illness or concomitant medication from the screening phase until study drug administration;

Sponsors & Collaborators

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

Study Sites (1)

The First Hospital of Jilin University

Jilin, Changchun, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Ding Yanhua, 硕士

CONTACT

18743062721; 1023307193@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 28, 2024
• Study Start: July 18, 2023
• Primary Completion: February 29, 2024
• Study Completion: March 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-01

Locations

CN (1)