HealthyPhase 1NCT04352361
Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects
A Phase 1 study testing TVB-2640 in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TVB-2640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 29 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 to 45 (including 18 and 45), both male and female(The 50mg dose half male and half female).
- Male weight ≥50 kg, female weight ≥45 kg; BMI between 19 and 24 kg/m2 (including boundary value).
- Those who have no family planning within half a year and are willing to take effective contraceptive measures within half a year after the last administration.
- Non-pregnant or lactating women.
- Voluntarily signing the informed consent.
Who cannot join
- Persons who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases (eye diseases such as corneal edema, keratitis, uveitis etc.) that can interfere with the test results.
- Previous corneal surgery, gastrointestinal surgery, vagus neurotomy, intestinal resection or any surgical operation that may interfere with gastrointestinal peristalsis, pH or absorption (except hernia repair, appendectomy).
- Persons with allergic constitution, including those with allergic history of drugs, food or other substances.
- Those who have used any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to administration.
- Any drugs that inhibit or induce the liver to metabolize drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin) were used within 30 days prior to administration; Inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal agents, HIV protease inhibitors, etc.), p-gp inducers (including rifampicin, st. John's wort, okazepine, and modafinil).
- Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the study.
Show all 19Show fewer
- Alcoholics or regular drinkers in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine).
- Drinking excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day for 3 months before the first administration.
- Anyone who has consumed or plans to consume any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) or foods rich in xanthine (such as sardines, animal livers, etc.) or beverages within 48 hours prior to the first use of the study drug.
- Had consumed or planned to consume grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or more fruit products within 3 days prior to administration.
- Patients who had donated blood or lost more than 400ml of blood within 3 months before administration.
- Patients who had participated in other clinical trials and received the study drug treatment within 3 months prior to the initial administration.
- Those who had used the first oral contraceptive pill within 30 days prior to the first administration, or those who had used long-acting estrogen or progesterone injections or implants within 6 months prior to the first administration.
- Those who had unprotected sex within 14 days before the first administration (female).
- Those who have special requirements on diet and cannot follow the unified diet.
- Those who have worn contact lenses or contact lenses within 7 days before medication administration.
- Those who fail the alcohol test or abuse the positive drug screening.
- Abnormal vital signs with clinical significance (normal range: 90 mmHg≤ systolic blood pressure <140 mmHg, 60 mmHg≤ diastolic blood pressure <90 mmHg, 60 beats/min ≤ pulse (resting) ≤100 beats/min;(subject to the judgment of the study physician) or medical examination, electrocardiogram, laboratory examination, breathalyzer test, drug abuse screening, etc.
- In addition to the above, the researchers judged that the patients were not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of TVB-2640 Tablets in Chinese Healthy Subjects
Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.
Read the detailed description
This study is designed as a single-center, randomized, single-blind, placebo-controlled, single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The next dose should be tested only if the previous dose has demonstrated to be safe and tolerated, and each subject will receive either the experimental drug or a placebo only once.
- Conditions
- Healthy
- Being tested
- TVB-2640, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVB-2640Drug
TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day.
PlaceboDrug
Oral, matching number of placebo Tablets with active arm.
| Study group | Role | What they receive |
|---|---|---|
| TVB-2640 tablets | Experimental | Not described Receives: Drug: TVB-2640 |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of TVB-2640 in Chinese healthy volunteers: adverse events and serious adverse events
Evaluation of number of patients reported with adverse events and serious adverse events.
Measured: Up to 4 days
Secondary outcomes (6)
Evaluate the Cmax of TVB-2640
Evaluate the Peak Plasma Concentration after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
Tmax of TVB-2640
Evaluate the Time to reach the maximum plasma concentration after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
AUC of TVB-2640
Evaluate the Area under the plasma concentration versus time curve after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
t1/2 of TVB-2640
Evaluate the Terminal-Phase Half-Life after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
CL/F of TVB-2640
Evaluate the Apparent Systemic Clearance after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
Vd/F of TVB-2640
Evaluate the Apparent Volume of Distribution after a single oral dose of TVB-2640 administered to Chinese healthy volunteers.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start2 Apr 2020
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, MD, Study director, Ascletis Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352361
- Sponsor's protocol ID
- 3V2640-CLIN-005-（I）-PK
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of TVB-2640 Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT04352361
- Acronym / sponsor ID
- 3V2640-CLIN-005-（I）-PK
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 20 Apr 2020 (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.
Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.
Detailed description
This study is designed as a single-center, randomized, single-blind, placebo-controlled, single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The next dose should be tested only if the previous dose has demonstrated to be safe and tolerated, and each subject will receive either the experimental drug or a placebo only once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVB-2640 tablets | Experimental | Drug: TVB-2640 |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18 to 45 (including 18 and 45), both male and female(The 50mg dose half male and half female).
- Male weight ≥50 kg, female weight ≥45 kg; BMI between 19 and 24 kg/m2 (including boundary value).
- Those who have no family planning within half a year and are willing to take effective contraceptive measures within half a year after the last administration.
- Non-pregnant or lactating women.
- Voluntarily signing the informed consent.
Key exclusion criteria (19 listed)
- Persons who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases (eye diseases such as corneal edema, keratitis, uveitis etc.) that can interfere with the test results.
- Previous corneal surgery, gastrointestinal surgery, vagus neurotomy, intestinal resection or any surgical operation that may interfere with gastrointestinal peristalsis, pH or absorption (except hernia repair, appendectomy).
- Persons with allergic constitution, including those with allergic history of drugs, food or other substances.
- Those who have used any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to administration.
- Any drugs that inhibit or induce the liver to metabolize drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin) were used within 30 days prior to administration; Inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal agents, HIV protease inhibitors, etc.), p-gp inducers (including rifampicin, st. John's wort, okazepine, and modafinil).
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 |
|---|---|---|
| TVB-2640TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day. | Drug | TVB-2640 tablets |
| PlaceboOral, matching number of placebo Tablets with active arm. | Drug | placebo |
Primary outcome
Evaluation of the safety and tolerability of TVB-2640 in Chinese healthy volunteers: adverse events and serious adverse events
Time frame: Up to 4 days
Evaluation of number of patients reported with adverse events and serious adverse events.
6 secondary outcomes
Evaluate the Cmax of TVB-2640
Time frame: Up to 3 days
Tmax of TVB-2640
Time frame: Up to 3 days
AUC of TVB-2640
Time frame: Up to 3 days
t1/2 of TVB-2640
Time frame: Up to 3 days
CL/F of TVB-2640
Time frame: Up to 3 days
Vd/F of TVB-2640
Time frame: Up to 3 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 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yahong Chen, MD study director
Ascletis Pharmaceuticals Co., Ltd.
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 TVB-2640 in people with Healthy, run by Ascletis Pharmaceuticals 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 19 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 7 Jul 2020. 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?
Evaluation of the safety and tolerability of TVB-2640 in Chinese healthy volunteers: adverse events and serious adverse events (time frame: Up to 4 days). 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 7 Jul 2020.