Phase 1Phase 1NCT06214858
The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects
A Phase 1 study testing SHEN211 tablets in people with Phase 1, run by JKT Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1
- What is being tested?
- SHEN211 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 30 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy subjects, ages 18-55 (including boundary values)
- The body weight of male subject is not less than 50.0kg, the body weight of female subject is not less than 45.0kg,Body mass index(BMI) in the range of 19.0 ~28.0kg/m2[BMI= weight (kg)/height 2 (m2)] (including the critical value)
- Subjects (including male subjects) are willing to be childfree from screening until 6 months after the last dose of the study drug, voluntarily use effective contraception (see Appendix I), and have no sperm donation plans; Women of childbearing age had to be assessed by a specialist as not pregnant and within 7 days of the start of their last menstrual period before enrollment.
- Sign informed consent before screening, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test protocol.
Who cannot join
- Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), coagulation function, infection marker examination, pregnancy examination (female only),12-lead electrocardiogram examination, chest X-ray examination, were determined by the investigator to be abnormal and clinically significant
- Any medical history or present medical history that may affect the subject's safety evaluation or study of the drug in vivo process, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (any history of gastrointestinal disorders that affect drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system disorders
- Those who had surgery within 3 months prior to screening or planned to have surgery during the study period, and those who had surgery that would affect drug absorption, distribution, metabolism, or excretion;
- Have a history of allergies to food, drugs, etc., or are known to be allergic to any component of this product
- People who have used any prescription drugs, over-the-counter drugs, Chinese herbs and health products within 2 weeks before screening;
- Any drug that inhibits or induces liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) used within 28 days prior to screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);
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- Those who received vaccination within 1 month prior to screening or planned to receive vaccination during the study period;
- Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ≈360mL beer or 45mL spirits with 40% alcohol or 150mL wine) in the three months prior to screening, or could not abstain during the test period, or had a positive alcohol breath at baseline;
- People who smoked an average of more than 5 cigarettes per day in the 3 months prior to the first administration of the study drug, or who could not stop using any tobacco products during the trial period;
- Blood donation or blood loss (≥400mL) within 3 months before screening, or blood transfusion;
- Those with a history of drug abuse within 6 months prior to screening;
- Those who had used drugs in the 3 months prior to screening, or who had positive urine screening at baseline;
- Participated in other drug clinical trials within 3 months prior to screening;
- Excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ≈250mL) in the 3 months before screening;
- Those who have special dietary requirements and cannot accept a unified diet;
- Dysphagia;
- Those with a history of infection (except a history of infection with the novel coronavirus);
- People who are lactose intolerant (those who have had diarrhea from drinking milk);
- Patients who cannot tolerate venipunction or have a history of needle fainting or blood fainting;
- Female subjects who are pregnant or breastfeeding;
- Participants considered inappropriate for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Jinan, Shandong, 250014
wei zhao, ph.D, 15131190710, zhao4wei2@hotmail.com
About this study
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
Read the detailed description
The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects.
- Conditions
- Phase 1
- Being tested
- SHEN211 tablets, SHEN211 placebo tablets
- Keywords
- SHEN211, Safety, tolerability, pharmacokinetics, food effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHEN211 tabletsDrug
SHEN211 tablets, tablets, specification: 0.11g, 10 tablets/box, storage: sealed, not more than 25℃ storage.
SHEN211 placebo tabletsDrug
placebo tablets, tablets, specification: 0g, 10 tablets/box, storage: sealed, not more than 25℃ storage.
| Study group | Role | What they receive |
|---|---|---|
| （Trial group）-SHEN211 tablets | Experimental | part 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. SHEN211 tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1).
part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg SHEN211 tablets D1 and 110mgSHEN211 tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg SHEN211 tablets on D1 and 220mg SHEN211 tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration. Receives: Drug: SHEN211 tablets |
| （Placebo group）-placebo tablets | Placebo comparator | part 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. placebo tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1).
part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg placebo tablets D1 and 110mg placebo tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg placebo tablets on D1 and 220mg placebo tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration. Receives: Drug: SHEN211 placebo tablets |
| （Food influence group）-SHEN211 tablets | Experimental | The dose of SHEN211 tablets 330mg was intended to be selected in this experiment. Subjects in group A took SHEN211 tablets 330mg orally on an empty stomach in the morning of the first day of the experiment (the first cycle). On the morning of the 12th day of the trial (the second cycle), SHEN211 tablets 330mg were taken orally once, 30min after starting to eat a high-fat high-calorie meal; Subjects in group B took SHEN211 tablets 330mg orally once in the morning of the first day of the trial (the first cycle) when they started to eat A high-fat and high-calorie meal for 30min, and took SHEN211 tablets 330mg orally in the morning of the 12th day of the trial (the second cycle) on an empty stomach. Receives: Drug: SHEN211 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability as assessed by AEs and SAEs
Measured: Up to day 63
Secondary outcomes (5)
Tmax
Peak time: The time required to reach peak concentration after administration
Measured: Up to day 63
Cmax
Peak concentration: The highest blood concentration after administration
Measured: Up to day 63
AUC
Area under the drug time curve: The area surrounded by the blood concentration curve to the time axis.
Measured: Up to day 63
λz
Terminal elimination rate: The terminal elimination rate constant is obtained from the semilog linear regression of the phase elimination concentration point
Measured: Up to day 63
t1/2
Terminal elimination half-life: The time required for the terminal phase blood concentration to decrease by half
Measured: Up to day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start14 Dec 2023
- Primary completion2 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JKT Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- wei zhao, ph.D, Principal investigator, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214858
- Sponsor's protocol ID
- DEU-1001
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects With Fasting Single or Multiple Oral Administration
- ClinicalTrials.gov ID
- NCT06214858
- Acronym / sponsor ID
- DEU-1001
- Conditions
- Phase 1
- Keywords
- SHEN211, Safety, tolerability, pharmacokinetics, food effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- JKT Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 2 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
Detailed description
The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| （Trial group）-SHEN211 tablets | Experimental | Drug: SHEN211 tabletspart 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. SHEN211 tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1). part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg SHEN211 tablets D1 and 110mgSHEN211 tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg SHEN211 tablets on D1 and 220mg SHEN211 tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration. |
| （Placebo group）-placebo tablets | Placebo comparator | Drug: SHEN211 placebo tabletspart 1：Four dose groups were set up: 110mg,330mg, 550mg and 770mg, each group was intended to include 2 subjects and was administered orally. placebo tablets in the corresponding dose group were given on fasting in the morning of D1. PK blood collection and related tests were completed on day 8 (D8), PK and safety tests were completed on day 10 (D10), and telephone follow-up was performed on day 14 (D14±1). part 2：Two dose groups were set up with 8 subjects in each group. In the first dose group, 330mg placebo tablets D1 and 110mg placebo tablets D2 ~ D5 were taken orally once a day (QD). The second dose group was taken orally 660mg placebo tablets on D1 and 220mg placebo tablets from D2 to D5, once a day (QD). PK samples were collected before and after administration, and safety observation was performed up to 8 days after the last administration. |
| （Food influence group）-SHEN211 tablets | Experimental | Drug: SHEN211 tabletsThe dose of SHEN211 tablets 330mg was intended to be selected in this experiment. Subjects in group A took SHEN211 tablets 330mg orally on an empty stomach in the morning of the first day of the experiment (the first cycle). On the morning of the 12th day of the trial (the second cycle), SHEN211 tablets 330mg were taken orally once, 30min after starting to eat a high-fat high-calorie meal; Subjects in group B took SHEN211 tablets 330mg orally once in the morning of the first day of the trial (the first cycle) when they started to eat A high-fat and high-calorie meal for 30min, and took SHEN211 tablets 330mg orally in the morning of the 12th day of the trial (the second cycle) on an empty stomach. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female healthy subjects, ages 18-55 (including boundary values)
- The body weight of male subject is not less than 50.0kg, the body weight of female subject is not less than 45.0kg,Body mass index(BMI) in the range of 19.0 ~28.0kg/m2[BMI= weight (kg)/height 2 (m2)] (including the critical value)
- Subjects (including male subjects) are willing to be childfree from screening until 6 months after the last dose of the study drug, voluntarily use effective contraception (see Appendix I), and have no sperm donation plans; Women of childbearing age had to be assessed by a specialist as not pregnant and within 7 days of the start of their last menstrual period before enrollment.
- Sign informed consent before screening, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test protocol.
Key exclusion criteria (21 listed)
- Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), coagulation function, infection marker examination, pregnancy examination (female only),12-lead electrocardiogram examination, chest X-ray examination, were determined by the investigator to be abnormal and clinically significant
- Any medical history or present medical history that may affect the subject's safety evaluation or study of the drug in vivo process, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (any history of gastrointestinal disorders that affect drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system disorders
- Those who had surgery within 3 months prior to screening or planned to have surgery during the study period, and those who had surgery that would affect drug absorption, distribution, metabolism, or excretion;
- Have a history of allergies to food, drugs, etc., or are known to be allergic to any component of this product
- People who have used any prescription drugs, over-the-counter drugs, Chinese herbs and health products within 2 weeks before screening;
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 |
|---|---|---|
| SHEN211 tabletsSHEN211 tablets, tablets, specification: 0.11g, 10 tablets/box, storage: sealed, not more than 25℃ storage. | Drug | （Food influence group）-SHEN211 tablets, （Trial group）-SHEN211 tablets |
| SHEN211 placebo tabletsplacebo tablets, tablets, specification: 0g, 10 tablets/box, storage: sealed, not more than 25℃ storage. | Drug | （Placebo group）-placebo tablets |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to day 63
Safety and Tolerability as assessed by AEs and SAEs
5 secondary outcomes
Tmax
Time frame: Up to day 63
Cmax
Time frame: Up to day 63
AUC
Time frame: Up to day 63
λz
Time frame: Up to day 63
t1/2
Time frame: Up to day 63
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- 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.
wei zhao, ph.D principal investigator
University of Paris 5 - Rene Descartes
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 SHEN211 tablets in people with Phase 1, run by JKT Biopharma 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 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact steve Shen, ph.D (18016406196, steve.shen@convalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to day 63). 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 22 Jan 2024.