Chronic Hepatitis bPhase 1XT1061NCT06280534
Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects
A Phase 1 study of Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to 31 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- ingestion of chocolate, any caffeinated or xanthine-containing food or beverage 24 hours prior to study drug administration;
- A positive urine drug screen or a history of substance abuse or drug use within the past five years;
- serum creatinine clearance ≤ 70 mL/min [formula: Ccr: (140 - age) × body weight (kg) / (0.818 × Scr) (μmol/L), female × 0.85].
- 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;
- Subjects who, in the opinion of the investigator, have other factors that make them unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Jilin City, Changchun
Ding Yanhua, master, 18743062721, 1023307193@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis b
- Being tested
- Test drug XT1061 capsules and placebo,Single dose group, Test drug XT1061 capsules and placebo，Multiple dosing group, Test drug XT1061 capsules and placebo，Food Impact Group
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test drug XT1061 capsules and placebo,Single dose groupDrug
Eight people took capsules of the test drug XT1061 and two people took a placebo.
Test drug XT1061 capsules and placebo，Multiple dosing groupDrug
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.
Test drug XT1061 capsules and placebo，Food Impact GroupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Test drug XT1061 capsules and placebo，Multiple dosing group |
| Food Impact Group | Experimental | 62.5 mg (i.e., single dose Group 4) Receives: Drug: Test drug XT1061 capsules and placebo，Food Impact Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Day 7
Cmax
Cmax
Measured: Day 4
Tmax
Tmax
Measured: Day 4
t1/2
t1/2
Measured: Day 4
AUC
AUC
Measured: Day 4
CL/F
CL/F
Measured: Day 4
Vz/F
Vz/F
Measured: Day 4
CLr/F
CLr/F
Measured: Day 4
Secondary outcomes (3)
Ae0-72 h
Ae0-72 h
Measured: Day 4
Fe0-72 h
Fe0-72 h
Measured: Day 4
bioavailability
geometric mean value ratio
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start18 Jul 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280534
- Sponsor's protocol ID
- XT1061-2022-01
- Acronym
- XT1061
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06280534
- Acronym / sponsor ID
- XT1061 / XT1061-2022-01
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.University, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose group | Experimental | Drug: Test drug XT1061 capsules and placebo,Single dose groupSingle 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). |
| Multiple dosing group | Experimental | Drug: Test drug XT1061 capsules and placebo，Multiple dosing groupMultiple administrations of 125mg, 250mg (groups 11, 12) Select one or both groups. |
| Food Impact Group | Experimental | Drug: Test drug XT1061 capsules and placebo，Food Impact Group62.5 mg (i.e., single dose Group 4) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test drug XT1061 capsules and placebo,Single dose groupEight people took capsules of the test drug XT1061 and two people took a placebo. | Drug | Single dose group |
| Test drug XT1061 capsules and placebo，Multiple dosing groupD1-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. | Drug | Multiple dosing group |
| Test drug XT1061 capsules and placebo，Food Impact GroupEight 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. | Drug | Food Impact Group |
Primary outcome
Treatment-related adverse events
Time frame: Day 7
Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.
Cmax
Time frame: Day 4
Cmax
Tmax
Time frame: Day 4
Tmax
t1/2
Time frame: Day 4
t1/2
AUC
Time frame: Day 4
AUC
CL/F
Time frame: Day 4
CL/F
Vz/F
Time frame: Day 4
Vz/F
CLr/F
Time frame: Day 4
CLr/F
3 secondary outcomes
Ae0-72 h
Time frame: Day 4
Fe0-72 h
Time frame: Day 4
bioavailability
Time frame: Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Chronic Hepatitis b, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ding Yanhua, 硕士 (18743062721, 1023307193@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.