Chronic HBV InfectionPhase 1NCT05851261

Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of PA3670 Tablets in Chinese Healthy Subjects

A Phase 1 study testing PA3670 in people with Chronic HBV Infection, run by Zhejiang Palo Alto Pharmaceuticals, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study are to evaluate the safety and tolerance of single and multiple oral administration of PA3670 tablets in Chinese adult healthy subjects and the effect of food on pharmacokinetics of PA3670 tablets in Chinese adult 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 HBV Infection
What is being tested?: PA3670
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: 13 Apr 2023to 19 Dec 2023
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

1. Healthy male and female subjects aged from 18 to 65 (inclusive);
2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) between 19 and 28 kg/m2 (including the critical value);
3. Be able to complete the test according to the study protocol;
4. Voluntary participation and signing of informed consent.

Who cannot join

1. There are any medical conditions that the investigator thinks may increase the risk of the subject participating in the study (especially the history of esophageal or gastrointestinal ulcer), may interfere with drug absorption, distribution, metabolism or excretion, or may weaken the compliance of the study protocol;
2. Allergic to the study drug or any component of the study drug, or allergic (refers to allergic to 2 or more kinds of food, drugs or environmental substances);
3. The vital signs, physical examination, laboratory examination (blood routine test, blood biochemistry, urine routine test, blood coagulation function, etc.), chest X-ray examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), 12 lead ECG, etc. in the screening period were judged abnormal and had clinical significance;
4. Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody and HIV antibody;
5. Those who regularly drank alcohol within 3 months before screening, i.e., those who drank more than 14 units of alcohol every week (1 unit=360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), or those who had positive alcohol breath test in the baseline period or could not stop drinking alcohol during the study period;
6. Those who smoke ≥ 5 cigarettes a day within 3 months before screening, those who are positive for nicotine test in the baseline period, or those who cannot stop using any tobacco products during the test period;

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7. Those who have a history of drug abuse and drug abuse in the past two years, or who are positive for urine screening of drug abuse at baseline (including morphine, methamphetamine, ketamine, benzodiazepine, cocaine, tetrahydrocannabinol acid);
8. Those who have used any drugs (prescription drugs, over-the-counter drugs, Chinese herbal medicine, vaccines) or health products within 4 weeks before screening and during screening;
9. Those who take any food or drink rich in caffeine and xanthine (coffee, tea, cola, chocolate, seafood, animal liver, etc.) within 48 hours before the first use of the study drug, or do not agree to stop eating the above diet during the test period;
10. Female subjects had unprotected sex in the past two weeks; Male subjects (or their partners) or female subjects who have fertility plans or donated sperm and eggs during the whole test period and within 3 months after administration, and who are unwilling to take one or more physical contraceptive measures or are breastfeeding during the test period;
11. Those who donate blood or lose a lot of blood (≥ 200 mL, except female physiological period) or use blood products or transfusions within 90 days before screening and during screening;
12. Those who participated in other clinical study within 90 days before screening or who participated in other clinical trials for less than 7 days;
13. Those who have undergone major surgery within 6 months before screening (judged by the researcher based on previous medical history data), suffered major trauma or planned to undergo surgery during the study period;
14. Difficulty in venous blood collection, or known history of needle and blood fainting;
15. Positive blood pregnancy test during screening period;
16. The investigator considers that there are other circumstances that are not suitable for participating in the test.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010

Other trials in China

About this study

Official title: Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of Single and Multiple Administration of Oral PA3670 Tablets in Chinese Healthy Subjects and the Effect of Food on Pharmacokinetics

Read the detailed description

Stage I: Single dose, Single Ascending Dose (SAD) This is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial.

The objective is to evaluate the safety, tolerability and pharmacokinetics characteristics of PA3670 tablets in Chinese healthy subjects. There are three dose groups of PA3670(5 mg、15 mg、30 mg) proposed to be tested sequentially in this study. A total of 30 healthy subjects are planned to be enrolled in this study and will be randomly assigned to the corresponding dose group in equal proportion, stratified by gender (male vs female). 10 subjects in each dose group are randomly assigned in a ratio of 4:1 to receive PA3670 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA3670 will be evaluated.

Stage Ⅱ: Multiple dose This is a randomized, double-blind, placebo-controlled, multiple dose clinical trial. A total of 10 subjects are planned to be enrolled in this study and will be randomly assigned in a ratio of 4:1 to receive 15mg PA3670 tablets or placebo. All subjects will be dosed for 9 consecutive days, and safety, tolerability and PK of PA3670 will be evaluated.

Stage Ⅲ: Study on the effect of food on Pharmacokinetics This is a randomized, open, two group crossover clinical trial. A total of 20 subjects are planned to be enrolled in this study, and will be randomly assigned to a dosing order (i.e. fasting administration followed by high-fat meal administration, or high-fat meal administration followed by fasting administration) in a ratio of 1:1. Subjects will be dosed 15 mg PA3670 tablets in a single dose, and the food-related PK of PA1010 will be evaluated.

Conditions: Chronic HBV Infection
Being tested: PA3670

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PA3670Drug
Placebo as control

Study groups in NCT05851261
Study group	Role	What they receive
PA3670 5 mg	Placebo comparator	Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA3670
PA3670 15 mg	Placebo comparator	Ten subjects will be randomly assigned in a ratio of 4:1 to receive 15 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA3670
PA3670 30 mg	Placebo comparator	Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA3670
PA3670 15 mg for 9days	Placebo comparator	Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 15mg of PA3670 tablets or PA3670 placebo tablets, once daily for 9 days. Receives: Drug: PA3670
PA3670 15mg before and after meals	Other	Ten subjects will be administered 15mg PA3670 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA3670 within 30 minutes after high-fat meal in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days. Receives: Drug: PA3670
PA3670 15mg after and before meals	Other	Ten subjects will be administered 15mg PA3670 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA3670 after overnight fasting 10 hours in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days. Receives: Drug: PA3670

What is being measured

The primary outcome is the main question the study is designed to answer.

Body temperature
Vital sign-body temperature
Measured: Up to 72 hours after last dose
Systolic and diastolic blood pressure
Vital sign-Systolic and diastolic blood pressure
Measured: Up to 72 hours after last dose
Pulse rate
Vital sign-Pulse rate
Measured: Up to 72 hours after last dose
Breathing rate
Vital sign-Breathing rate
Measured: Up to 72 hours after last dose
Number of subjects having abnormal hematology laboratory parameters
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: Up to 72 hours after last dose
Number of subjects with abnormal clinical chemistry parameters
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: Up to 72 hours after last dose
Number of subjects with abnormal values for urinalysis
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: Up to 72 hours after last dose
Number of subjects with abnormal with blood coagulation function
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: Up to 72 hours after last dose
ECG parameter-QTc interval
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval
Measured: Up to 72 hours after last dose
ECG parameter-PR interval
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR interval.
Measured: Up to 72 hours after last dose
ECG parameter-QRS duration
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration
Measured: Up to 72 hours after last dose
Number of subjects experiencing adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Measured: 7 days or 15 days

Secondary outcomes (3)

Pharmacokinetics of PA3670-Cmax
Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Maximum Observed Plasma Concentration (Cmax)
Measured: 4 days or 12 days
Pharmacokinetics of PA3670-Tmax
Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 4 days or 12 days
Pharmacokinetics of single dose of PA3670-AUC
Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Area Under the Plasma Concentration-Time Curve (AUC)
Measured: 4 days or 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202319 Dec 2023

First posted9 May 2023
Study start13 Apr 2023
Primary completion24 Oct 2023
Study completion19 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic HBV InfectionStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05851261
Sponsor's protocol ID: PA3670-101
Status last verified: Apr 2024
First submitted: 8 Feb 2023
Last updated: 16 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic HBV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics Characteristics of Single and Multiple Administration of Oral PA3670 Tablets in Chinese Healthy Subjects and the Effect of Food on Pharmacokinetics
ClinicalTrials.gov ID: NCT05851261
Acronym / sponsor ID: PA3670-101
Conditions: Chronic HBV Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Zhejiang Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 13 Apr 2023 (actual)
Primary completion: 24 Oct 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 9 May 2023 (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.

Detailed description

Stage I: Single dose, Single Ascending Dose (SAD) This is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
PA3670 5 mg	Placebo comparator	Drug: PA3670Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.
PA3670 15 mg	Placebo comparator	Drug: PA3670Ten subjects will be randomly assigned in a ratio of 4:1 to receive 15 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.
PA3670 30 mg	Placebo comparator	Drug: PA3670Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days.
PA3670 15 mg for 9days	Placebo comparator	Drug: PA3670Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 15mg of PA3670 tablets or PA3670 placebo tablets, once daily for 9 days.
PA3670 15mg before and after meals	Other	Drug: PA3670Ten subjects will be administered 15mg PA3670 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA3670 within 30 minutes after high-fat meal in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days.
PA3670 15mg after and before meals	Other	Drug: PA3670Ten subjects will be administered 15mg PA3670 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA3670 after overnight fasting 10 hours in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1. Healthy male and female subjects aged from 18 to 65 (inclusive);
2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) between 19 and 28 kg/m2 (including the critical value);
3. Be able to complete the test according to the study protocol;
4. Voluntary participation and signing of informed consent.

Key exclusion criteria (16 listed)

1. There are any medical conditions that the investigator thinks may increase the risk of the subject participating in the study (especially the history of esophageal or gastrointestinal ulcer), may interfere with drug absorption, distribution, metabolism or excretion, or may weaken the compliance of the study protocol;
2. Allergic to the study drug or any component of the study drug, or allergic (refers to allergic to 2 or more kinds of food, drugs or environmental substances);
3. The vital signs, physical examination, laboratory examination (blood routine test, blood biochemistry, urine routine test, blood coagulation function, etc.), chest X-ray examination, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), 12 lead ECG, etc. in the screening period were judged abnormal and had clinical significance;
4. Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody and HIV antibody;
5. Those who regularly drank alcohol within 3 months before screening, i.e., those who drank more than 14 units of alcohol every week (1 unit=360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), or those who had positive alcohol breath test in the baseline period or could not stop drinking alcohol during the study period;

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
PA3670Placebo as control	Drug	PA3670 15 mg, PA3670 15 mg for 9days, PA3670 15mg after and before meals, PA3670 15mg before and after meals, PA3670 30 mg, PA3670 5 mg

Primary outcome

Body temperature
Time frame: Up to 72 hours after last dose
Vital sign-body temperature
Systolic and diastolic blood pressure
Time frame: Up to 72 hours after last dose
Vital sign-Systolic and diastolic blood pressure
Pulse rate
Time frame: Up to 72 hours after last dose
Vital sign-Pulse rate
Breathing rate
Time frame: Up to 72 hours after last dose
Vital sign-Breathing rate
Number of subjects having abnormal hematology laboratory parameters
Time frame: Up to 72 hours after last dose
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Number of subjects with abnormal clinical chemistry parameters
Time frame: Up to 72 hours after last dose
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Number of subjects with abnormal values for urinalysis
Time frame: Up to 72 hours after last dose
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Number of subjects with abnormal with blood coagulation function
Time frame: Up to 72 hours after last dose
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
ECG parameter-QTc interval
Time frame: Up to 72 hours after last dose
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval
ECG parameter-PR interval
Time frame: Up to 72 hours after last dose
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR interval.
ECG parameter-QRS duration
Time frame: Up to 72 hours after last dose
A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration
Number of subjects experiencing adverse events (AEs)
Time frame: 7 days or 15 days
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.

3 secondary outcomes

Pharmacokinetics of PA3670-Cmax
Time frame: 4 days or 12 days
Pharmacokinetics of PA3670-Tmax
Time frame: 4 days or 12 days
Pharmacokinetics of single dose of PA3670-AUC
Time frame: 4 days or 12 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.

Related trials for Chronic HBV Infection

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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.

Hong Ren, MD principal investigator

The Second Affiliated Hospital of Chongqing Medical University

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 testing PA3670 in people with Chronic HBV Infection, run by Zhejiang Palo Alto Pharmaceuticals, Inc. 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 16 Apr 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body temperature (time frame: Up to 72 hours after last dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05851261.

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 16 Apr 2024.