Chronic Hepatitis BPhase 1NCT03173599
The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
A Phase 1 study testing PNA 40mg, PNA 80mg and PNA 160mg in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
Trial summary
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PNA 40mg, PNA 80mg and PNA 160mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Apr 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 45 years old ;
- Body mass index (BMI) above/equal 18 and below 28 kg/m2;
- Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;
- No smoking in a year before post-dosing of study drug;
- Give their signed written informed consent to participate.
Who cannot join
- Subjects who have clinically significant abnormal laboratory test results;
- Subjects with clinically significant abnormal ECG;
- Subjects with cardiac or blood disease affecting the safety and pharmacokinetics;
- Subjects with liver or renal disease affecting the safety and pharmacokinetics;
- Subjects with digestive system disease affecting the safety of study drug;
- Subjects with other acute or chronic disease affecting pharmacokinetics and product metabolism;
Show all 17Show fewer
- A positive hepatitis B surface antigen, hepatitis C or HIV test result;
- History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes;
- Subjects, who in the opinion of the investigator, significantly abuse alcohol;
- Drink in 36 hours before post-dosing of study drug;
- Ingest any foods or beverages which may affect pharmacokinetics;
- Drug abuse,a history of poisoning;
- Smokers(use tobacco products in a year before post-dosing of study drug);
- Subjects who had received other medications within 2 weeks prior to the first administration of Investigational Product,and the original and main metabolites were not completely eliminated;
- Subjects who participated in any other clinical trials within 3 months prior to the administration of Investigational Product;
- Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded; 17. Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the administration of Investigational Product;
- 18．Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions; 19．Haven't given their signed written informed consent to participate; 20．Subjects in the opinion of the investigator, could not participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design Conducted in Chinese Healthy Adult Volunteers
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
Read the detailed description
A study to evaluate the safety and tolerability of ascending single oral doses of metacavir enteric-coated capsules using a placebo-controlled design conducted in Chinese healthy adult volunteers, and to provide references for the clinical trial of the next phase Ⅰ and Ⅱ.
48 eligible healthy subjects are involved. According to the set ascending-doses groups, subjects will be randomized in a 3:1 proportion to orally take a single dose of Metacavir enteric-coated capsule or placebo on the condition of fasting. Each group has 8 people, evenly composed of men and women. The beginning dose of the study is 40mg/d.According to the dose escalation method, subjects who have successfully completed tests of the previous dose group and passed the safety assessment will enter the next dose group with the same method. All subjects check in the phaseⅠresearch center one day early before taking the test drug. Vital signs and ECG will be observed before and 0.5,1,2,4,8,12,18,24,48,72 hours after administration and at the follow-up day which is the 7th day since administration. Laboratory tests will be conducted before and 6,24,48,72 hours after administration and at the follow-up day , and the adverse drug events are observed throughout the test.
- Conditions
- Chronic Hepatitis B
- Being tested
- PNA 40mg, PNA 80mg, PNA 160mg, PNA 240mg, PNA 360mg
- Keywords
- Chronic Hepatitis B
- 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.
PNA 40mgDrug
Also called Metacavir Enteric-coated Capsules 40mg
The beginning dose is 40mg.
PNA 80mgDrug
Also called Metacavir Enteric-coated Capsules 80mg
The single dose is 80mg.
PNA 160mgDrug
Also called Metacavir Enteric-coated Capsules 160mg
The single dose is 160mg.
PNA 240mgDrug
Also called Metacavir Enteric-coated Capsules 240mg
The single dose is 240mg.
PNA 360mgDrug
Also called Metacavir Enteric-coated Capsules 360mg
The single dose is 360mg.
PNA 480mgDrug
Also called Metacavir Enteric-coated Capsules 480mg
The single dose is 480mg.
PNA PlaceboDrug
Also called Metacavir Enteric-coated Capsules Placebo
The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.
| Study group | Role | What they receive |
|---|---|---|
| PNA 40mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The beginning dose is 40mg,If no adverse effects were observed in 40 mg, the next dose group was started of 80mg. Receives: Drug: PNA 40mg |
| PNA 80mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The single dose is 80mg,If no adverse effects were observed in 80 mg, the next dose group was started of 160mg. Receives: Drug: PNA 80mg |
| PNA 160mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The single dose is 160mg,If no adverse effects were observed in 160 mg, the next dose group was started of 240mg. Receives: Drug: PNA 160mg |
| PNA 240mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The single dose is 240mg,If no adverse effects were observed in 240 mg, the next dose group was started of 360mg. Receives: Drug: PNA 240mg |
| PNA 360mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The single dose is 360mg,If no adverse effects were observed in 360 mg, the next dose group was started of 480mg. Receives: Drug: PNA 360mg |
| PNA 480mg | Experimental | Metacavir Enteric-coated Capsules,oral before meal
The single dose is 480mg. Receives: Drug: PNA 480mg |
| PNA Placebo | Placebo comparator | Metacavir Enteric-coated Capsules Placebo,oral before meal
The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg Receives: Drug: PNA Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events refer to any adverse and unexpected vital signs and laboratory tests，symptoms or temporary illness.
Measured: Baseline, up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yimin Mao, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173599
- Sponsor's protocol ID
- PNA20100714
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design Conducted in Chinese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03173599
- Acronym / sponsor ID
- PNA20100714
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Jun 2017 (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 Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
Detailed description
A study to evaluate the safety and tolerability of ascending single oral doses of metacavir enteric-coated capsules using a placebo-controlled design conducted in Chinese healthy adult volunteers, and to provide references for the clinical trial of the next phase Ⅰ and Ⅱ.
48 eligible healthy subjects are involved. According to the set ascending-doses groups, subjects will be randomized in a 3:1 proportion to orally take a single dose of Metacavir enteric-coated capsule or placebo on the condition of fasting. Each group has 8 people, evenly composed of men and women. The beginning dose of the study is 40mg/d.According to the dose escalation method, subjects who have successfully completed tests of the previous dose group and passed the safety assessment will enter the next dose group with the same method. All subjects check in the phaseⅠresearch center one day early before taking the test drug. Vital signs and ECG will be observed before and 0.5,1,2,4,8,12,18,24,48,72 hours after administration and at the follow-up day which is the 7th day since administration. Laboratory tests will be conducted before and 6,24,48,72 hours after administration and at the follow-up day , and the adverse drug events are observed throughout the test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PNA 40mg | Experimental | Drug: PNA 40mgMetacavir Enteric-coated Capsules,oral before meal The beginning dose is 40mg,If no adverse effects were observed in 40 mg, the next dose group was started of 80mg. |
| PNA 80mg | Experimental | Drug: PNA 80mgMetacavir Enteric-coated Capsules,oral before meal The single dose is 80mg,If no adverse effects were observed in 80 mg, the next dose group was started of 160mg. |
| PNA 160mg | Experimental | Drug: PNA 160mgMetacavir Enteric-coated Capsules,oral before meal The single dose is 160mg,If no adverse effects were observed in 160 mg, the next dose group was started of 240mg. |
| PNA 240mg | Experimental | Drug: PNA 240mgMetacavir Enteric-coated Capsules,oral before meal The single dose is 240mg,If no adverse effects were observed in 240 mg, the next dose group was started of 360mg. |
| PNA 360mg | Experimental | Drug: PNA 360mgMetacavir Enteric-coated Capsules,oral before meal The single dose is 360mg,If no adverse effects were observed in 360 mg, the next dose group was started of 480mg. |
| PNA 480mg | Experimental | Drug: PNA 480mgMetacavir Enteric-coated Capsules,oral before meal The single dose is 480mg. |
| PNA Placebo | Placebo comparator | Drug: PNA PlaceboMetacavir Enteric-coated Capsules Placebo,oral before meal The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged 18 to 45 years old ;
- Body mass index (BMI) above/equal 18 and below 28 kg/m2;
- Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;
- No smoking in a year before post-dosing of study drug;
- Give their signed written informed consent to participate.
Key exclusion criteria (17 listed)
- Subjects who have clinically significant abnormal laboratory test results;
- Subjects with clinically significant abnormal ECG;
- Subjects with cardiac or blood disease affecting the safety and pharmacokinetics;
- Subjects with liver or renal disease affecting the safety and pharmacokinetics;
- Subjects with digestive system disease affecting the safety of 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 |
|---|---|---|
| PNA 40mgAlso: Metacavir Enteric-coated Capsules 40mgThe beginning dose is 40mg. | Drug | PNA 40mg |
| PNA 80mgAlso: Metacavir Enteric-coated Capsules 80mgThe single dose is 80mg. | Drug | PNA 80mg |
| PNA 160mgAlso: Metacavir Enteric-coated Capsules 160mgThe single dose is 160mg. | Drug | PNA 160mg |
| PNA 240mgAlso: Metacavir Enteric-coated Capsules 240mgThe single dose is 240mg. | Drug | PNA 240mg |
| PNA 360mgAlso: Metacavir Enteric-coated Capsules 360mgThe single dose is 360mg. | Drug | PNA 360mg |
| PNA 480mgAlso: Metacavir Enteric-coated Capsules 480mgThe single dose is 480mg. | Drug | PNA 480mg |
| PNA PlaceboAlso: Metacavir Enteric-coated Capsules PlaceboThe beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg. | Drug | PNA Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Baseline, up to Day 7
Adverse Events refer to any adverse and unexpected vital signs and laboratory tests，symptoms or temporary illness.
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 2 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Yimin Mao principal investigator
RenJi Hospital
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 PNA 40mg, PNA 80mg and PNA 160mg in people with Chronic Hepatitis B, run by Guangzhou Yipinhong Pharmaceutical 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 5 inclusion and 17 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 2 Jun 2017. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Baseline, up to Day 7). 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 2 Jun 2017.