Chronic HBV InfectionPhase 1NCT05468060
Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy Subjects
A Phase 1 study testing PA1010 in people with Chronic HBV Infection, run by Zhejiang Palo Alto Pharmaceuticals, Inc. at 1 site in China.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetics characteristics of single ascending dose (SAD) of PA1010 tablets in Chinese healthy adults and the impact of food and gender on the pharmacokinetics Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- PA1010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2020to 12 Dec 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged between 18 and 55 (including upper and lower limits);
- Body mass index (BMI) is between 18 and 28 kg/m2 (including upper and lower limits);
- During the study period (from signing the informed consent to the last follow-up) and within 90 days after the last dose, there is no possibility of pregnancy (or making the sexual partner pregnant), childbirth or lactation, including:
- Menopausal women who have menopause for more than 12 months or undergo sterilization (such as hysterectomy or bilateral ovariectomy);
- Postmenopausal women, who have negative urine pregnancy test within 24 hours before the first dose, are willing to take more than one effective contraceptive method from the screening period to 90 days after the last dose, including intrauterine device, fallopian tube ligation, double barrier method (condom / vaginal diaphragm + spermicide) and male partner vas deferens ligation, but do not include oral contraceptives;
- Men are willing to take more than one effective contraceptive method from the first dose to 90 days after the last dose, including vasectomy, double barrier method, female partner's use of contraceptives, intrauterine device or tubal ligation, etc.;
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- Avoid sex during the study period to 90 days after the last dose;
- There is no history of major diseases, and the physical examination, vital signs, electrocardiogram and laboratory examination results during the screening period are normal, or although they exceed the normal reference value range, they are judged by the researcher to be of no clinical significance;
- Be able to communicate with clinical staff normally and comply with the requirements of this study;
- Sign the informed consent form to indicate willingness to participate in this study.
Who cannot join
- Any medical condition that the investigator considers to be likely to increase the risk of study participation (in particular, a history of esophageal or gastrointestinal ulcers), that may interfere with drug absorption, distribution, metabolism, or excretion, or that may impair adherence to the study protocol;
- Those who have received any other study drug within 90 days before the first dose of the study drug;
- Those who have received other prescription or over-the-counter drugs that will effect the study evaluation considered by the investigator that within 14 days prior to the first administration of the study drug (or within 5 half-lives of the drug, whichever is longer）；
- Those who have donated blood or lost a lot of blood (>400 ml) within 3 months before the first dose of the study drug;
- Major surgery or great trauma within 6 months before the first dose of the study drug (the investigator make the judgement based on the previous medical history);
- Consumption of beverages or foods containing grapefruit, pomegranate, papaya, grapes, carambola within 14 days, or do not agree to refrain from taking those beverages or foods every day during the study；
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- Any alcoholic products within 48 hours before the first administration of the study drug, or disagree to refrain from taking any alcohol products every day during the study;
- Any foods or beverages rich in caffeine and xanthine within 48 hours before the first dose of the study drug(coffee, tea, coke, chocolate, seafood, animal liver, etc.) or disagree to refrain from taking those foods and beverages every day during the study;
- Abnormal ECG during screening or baseline period, which is judged to be clinically significant by the investigator; Or QTcF > 450 ms during screening or baseline period；
- History of heart disease, including a family history of sudden death caused by cardiac causes or QT interval prolongation syndrome;
- History of serious kidney disease (judged by the investigator);
- Difficulty in venous blood collection, or known to have a history of needle fainting and blood fainting for many times;
- Clinical or laboratory evidence shows that there is one of the following situations: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), syphilis carrying / infection;
- Any history of food and drug allergy of clinical significance judged by the investigator;
- Any history of drug abuse or urine drug test (+) in the screening period within 1 year before the first administration of the study drug;
- Regular drinking history within 6 months before screening. Women have more than 7 cups / week, men have more than 14 cups / week (1 cup =5 ounces of wine or 12 ounces of beer or 1.5 ounces of spirits) or the alcohol test exceeds the standard during the screening period;
- Those who cannot quit smoking as required during the study period or whose cigarette test paper (urine nicotine test) is positive during the screening period;
- Participated in this study before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics of Single Ascending Dose (SAD) of PA1010 Tablets in Chinese Healthy Subjects and the Effects of Food and Gender on Pharmacokinetics
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetics characteristics of single ascending dose (SAD) of PA1010 tablets in Chinese healthy adults and the impact of food and gender on the 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 PA1010 tablets in Chinese healthy subjects. There are six dose groups of PA1010 ( 5 mg、10 mg、20 mg、30 mg、45 mg and 60 mg) proposed to be tested sequentially in this study. A total of 60 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 PA1010 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA1010 will be evaluated.
Stage II: Study on the effect of food on Pharmacokinetics
This is a single center, randomized, open, two group crossover, self-control 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 10 mg PA1010 tablets in a single dose, and the food-related PK of PA1010 will be evaluated.
- Conditions
- Chronic HBV Infection
- Being tested
- PA1010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA1010Drug
Placebo as control
| Study group | Role | What they receive |
|---|---|---|
| PA1010 5mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA1010 tablets or 5mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 10mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 10mg of PA1010 tablets or 10mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 20mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 20mg of PA1010 tablets or 20mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 30mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30mg of PA1010 tablets or 30mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 45mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 45mg of PA1010 tablets or 45mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 60mg | Experimental | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 60mg of PA1010 tablets or 60mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. Receives: Drug: PA1010 |
| PA1010 10mg before and after meals | Experimental | Ten subjects will be administered 10mg PA1010 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA1010 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 10 days. Receives: Drug: PA1010 |
| PA1010 10mg after and before meals | Experimental | Ten subjects will be administered 10mg PA1010 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA1010 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 10 days. Receives: Drug: PA1010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Ear temperature
Vital sign-ear 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
ECG parameter-QTc interval
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically calculates the QTc intervals
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 intervals
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: Up to 4days after the last dose
Pharmacokinetics of single dose of PA1010-Cmax
Blood samples will be collected serially, and the concentrations of PA1010 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: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-Tmax
Blood samples will be collected serially, and the concentrations of PA1010 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: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-AUC
Blood samples will be collected serially, and the concentrations of PA1010 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: Up to 72 hours after last dose
Secondary outcomes (4)
Pharmacokinetics of single dose of PA1010-T1/2
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Elimination Half-Life Period (T1/2）
Measured: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-Vz/F
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Apparent Volume of Distribution(Vz/F)
Measured: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-λz
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Elimination Rate Constant(λz)
Measured: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-CL/F
Blood samples will be collected serially, and the concentrations of PA1010 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Apparent Clearance(CL/F)
Measured: Up to 72 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start28 Jun 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuebing Yan, MD, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468060
- Sponsor's protocol ID
- PA1010-101
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 21 Jul 2022
- 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics of Single Ascending Dose (SAD) of PA1010 Tablets in Chinese Healthy Subjects and the Effects of Food and Gender on Pharmacokinetics
- ClinicalTrials.gov ID
- NCT05468060
- Acronym / sponsor ID
- PA1010-101
- Conditions
- Chronic HBV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhejiang Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 21 Jul 2022 (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.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetics characteristics of single ascending dose (SAD) of PA1010 tablets in Chinese healthy adults and the impact of food and gender on the pharmacokinetics
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 PA1010 tablets in Chinese healthy subjects. There are six dose groups of PA1010 ( 5 mg、10 mg、20 mg、30 mg、45 mg and 60 mg) proposed to be tested sequentially in this study. A total of 60 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 PA1010 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA1010 will be evaluated.
Stage II: Study on the effect of food on Pharmacokinetics
This is a single center, randomized, open, two group crossover, self-control 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 10 mg PA1010 tablets in a single dose, and the food-related PK of PA1010 will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PA1010 5mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA1010 tablets or 5mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 10mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 10mg of PA1010 tablets or 10mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 20mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 20mg of PA1010 tablets or 20mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 30mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30mg of PA1010 tablets or 30mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 45mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 45mg of PA1010 tablets or 45mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 60mg | Experimental | Drug: PA1010Ten subjects will be randomly assigned in a ratio of 4:1 to receive 60mg of PA1010 tablets or 60mg of PA1010 placebo tablets. They will be administered a single dose and observed for four days. |
| PA1010 10mg before and after meals | Experimental | Drug: PA1010Ten subjects will be administered 10mg PA1010 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA1010 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 10 days. |
| PA1010 10mg after and before meals | Experimental | Drug: PA1010Ten subjects will be administered 10mg PA1010 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA1010 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 10 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects aged between 18 and 55 (including upper and lower limits);
- Body mass index (BMI) is between 18 and 28 kg/m2 (including upper and lower limits);
- During the study period (from signing the informed consent to the last follow-up) and within 90 days after the last dose, there is no possibility of pregnancy (or making the sexual partner pregnant), childbirth or lactation, including:
- There is no history of major diseases, and the physical examination, vital signs, electrocardiogram and laboratory examination results during the screening period are normal, or although they exceed the normal reference value range, they are judged by the researcher to be of no clinical significance;
- Be able to communicate with clinical staff normally and comply with the requirements of this study;
Key exclusion criteria (18 listed)
- Any medical condition that the investigator considers to be likely to increase the risk of study participation (in particular, a history of esophageal or gastrointestinal ulcers), that may interfere with drug absorption, distribution, metabolism, or excretion, or that may impair adherence to the study protocol;
- Those who have received any other study drug within 90 days before the first dose of the study drug;
- Those who have received other prescription or over-the-counter drugs that will effect the study evaluation considered by the investigator that within 14 days prior to the first administration of the study drug (or within 5 half-lives of the drug, whichever is longer）；
- Those who have donated blood or lost a lot of blood (>400 ml) within 3 months before the first dose of the study drug;
- Major surgery or great trauma within 6 months before the first dose of the study drug (the investigator make the judgement based on the previous medical history);
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 |
|---|---|---|
| PA1010Placebo as control | Drug | PA1010 10mg, PA1010 10mg after and before meals, PA1010 10mg before and after meals, PA1010 20mg, PA1010 30mg, PA1010 45mg, PA1010 5mg, PA1010 60mg |
Primary outcome
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.
Ear temperature
Time frame: Up to 72 hours after last dose
Vital sign-ear 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
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 calculates the QTc intervals
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 intervals
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: Up to 4days after the last dose
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.
Pharmacokinetics of single dose of PA1010-Cmax
Time frame: Up to 72 hours after last dose
Blood samples will be collected serially, and the concentrations of PA1010 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)
Pharmacokinetics of single dose of PA1010-Tmax
Time frame: Up to 72 hours after last dose
Blood samples will be collected serially, and the concentrations of PA1010 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)
Pharmacokinetics of single dose of PA1010-AUC
Time frame: Up to 72 hours after last dose
Blood samples will be collected serially, and the concentrations of PA1010 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)
4 secondary outcomes
Pharmacokinetics of single dose of PA1010-T1/2
Time frame: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-Vz/F
Time frame: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-λz
Time frame: Up to 72 hours after last dose
Pharmacokinetics of single dose of PA1010-CL/F
Time frame: Up to 72 hours after last dose
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 21 Jul 2022.
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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.
Xuebing Yan, MD principal investigator
The Affiliated Hospital of Xuzhou 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 PA1010 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 10 inclusion and 18 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 21 Jul 2022. 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?
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?
Number of subjects having abnormal hematology laboratory parameters (time frame: Up to 72 hours after last dose). The study lists 15 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 21 Jul 2022.