Diabetic Peripheral NeuropathyPhase 1NCT04453618
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects
A Phase 1 study testing FE-SYHA1402 100mg, SYHA1402-25mg and SYHA1402-50mg in people with Diabetic Peripheral Neuropathy, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- FE-SYHA1402 100mg, SYHA1402-25mg and SYHA1402-50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 18 to 45 years (inclusive).
- Have a body mass index (BMI) between 19.0 and 26.0 kg/m2 inclusive and weigh at least 45.0 kg (female) or 50.0 kg (male) inclusive at screening.
- With no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests.
- All subjects of reproductive potential must agree to use effective, non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs) from the signing of informed consent to 3 months after the study. A subject is eligible to participate if she/he is not a person of childbearing potential (had a bilateral oophorectomy, bilateral salpingo-oophorectomy, or vasectomy). A male subject refrains from donating sperm during the study period and for 3 months after the study.
- Signed informed consent form.
Who cannot join
- Female subjects who are pregnant or lactating.
- History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, renal, or other major disease, as determined by the investigator.
- Surgery history within six months before signing the informed consent;
- Allergic history to more than one drug or other serious allergic history.
- Any other abnormal findings on vital signs
- Any clinically significant abnormalities in ECG: a QTc interval greater than 450 ms (male) or 470 ms (female), or with a history of prolonged QTc interval;
Show all 16Show fewer
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (anti-HCV), Human immunodeficiency virus antibody (anti-HIV) or Treponema Pallidum antibody (Anti-TP) at screening.
- Use of drugs within 2 weeks before signing the informed consent, including over-the-counter or prescription medication, including biological product, Chinese traditional medicine, herbal medicine, vitamin dietary supplements, health care products, oral or imbedded long-acting contraceptives.
- Alcohol abuse or positive test for alcohol screening.
- Smoker.
- History or clinical evidence of drug abuse within the one years before screening, or positive test for drug abuse at screening.
- Use of too much caffeine in beverages, foods or in any form, which may interfere the absorption, distribution, metabolism, or excretion of drugs, within 4 weeks before signing informed consent
- Loss of blood or blood donation more than 200 mL within 8 weeks before signing informed consent, or plan on blood donation during the study period and 1 months after the last dose of drug.
- Have a surgical schedule or a plan on excessive physical activity during the study period.
- Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;
- Not suitable for this trial as determined by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Food Effect of a Tablet Formulation of SYHA1402 in Healthy Subjects: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study
A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.
Read the detailed description
This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402.
The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses.
Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- FE-SYHA1402 100mg, SYHA1402-25mg, Placebo-25mg, SYHA1402-50mg, Placebo-50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE-SYHA1402 100mgDrug
in either a fasted state or with a meal
SYHA1402-25mgDrug
SYHA1402 25mg, oral tablets
Placebo-25mgDrug
Matching placebo tablets
SYHA1402-50mgDrug
SYHA1402 50mg, oral tablets
Placebo-50mgDrug
Matching placebo tablets
SYHA1402-150mgDrug
SYHA1402 150mg, oral tablets
Placebo-150mgDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Food effect | Experimental | Healthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal. Receives: Drug: FE-SYHA1402 100mg |
| Multiple doses 25mg | Experimental | Healthy subjects receive multiple doses of SYHA1402 (25mg) or Placebo(25mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. Receives: Drug: SYHA1402-25mg; Drug: Placebo-25mg |
| Multiple doses 50mg | Experimental | Healthy subjects receive multiple doses of SYHA1402 (50mg) or Placebo (50mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. Receives: Drug: SYHA1402-50mg; Drug: Placebo-50mg |
| Multiple doses 150mg | Experimental | Healthy subjects receive multiple doses of SYHA1402 (150mg) or Placebo (150mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. Receives: Drug: SYHA1402-150mg; Drug: Placebo-150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of food on the pharmacokinetic(Cmax）
Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).
Measured: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic(AUC0-inf）
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).
Measured: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic(AUC0-t）
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).
Measured: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).
incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Measured: up to 5 days after the last dose
Secondary outcomes (12)
Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)
incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
Measured: up to 4 days after the last dose
AUC0-t(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
Measured: Predose and multiple timepoints up to 24 hours after the last dose
AUC0-inf(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Cmax(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the maximum measured concentration of the analyte in plasma
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Tmax(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Time to Reach Maximum Observed Concentration
Measured: Predose and multiple timepoints up to 24 hours after the last dose
t1/2z(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Terminal Elimination Half-life
Measured: Predose and multiple timepoints up to 24 hours after the last dose
CL/F(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Vz/F(Part2)
Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Rac(AUC)(Part2)
Rate and Extent of Absorption of SYHA1402 by Assessment of the Accumulation Ratio
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Rac(Cmax) (Part2)
Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax
Measured: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on Cmax (Part2)
The assessment of the dose-proportionality in the plasma pharmacokinetics (Cmax) of SYHA1402
Measured: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on AUC (Part2)
The assessment of the dose-proportionality in the plasma pharmacokinetics (AUC) of SYHA1402
Measured: Predose and multiple timepoints up to 24 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453618
- Sponsor's protocol ID
- HA1403-CSP-002；V1.0
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 1 Jul 2020
- 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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Food Effect of a Tablet Formulation of SYHA1402 in Healthy Subjects: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT04453618
- Acronym / sponsor ID
- HA1403-CSP-002；V1.0
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Jul 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.
A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.
Detailed description
This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402.
The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses.
Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Food effect | Experimental | Drug: FE-SYHA1402 100mgHealthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal. |
| Multiple doses 25mg | Experimental | Drug: SYHA1402-25mg, Drug: Placebo-25mgHealthy subjects receive multiple doses of SYHA1402 (25mg) or Placebo(25mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. |
| Multiple doses 50mg | Experimental | Drug: SYHA1402-50mg, Drug: Placebo-50mgHealthy subjects receive multiple doses of SYHA1402 (50mg) or Placebo (50mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. |
| Multiple doses 150mg | Experimental | Drug: SYHA1402-150mg, Drug: Placebo-150mgHealthy subjects receive multiple doses of SYHA1402 (150mg) or Placebo (150mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects aged 18 to 45 years (inclusive).
- Have a body mass index (BMI) between 19.0 and 26.0 kg/m2 inclusive and weigh at least 45.0 kg (female) or 50.0 kg (male) inclusive at screening.
- With no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests.
- All subjects of reproductive potential must agree to use effective, non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs) from the signing of informed consent to 3 months after the study. A subject is eligible to participate if she/he is not a person of childbearing potential (had a bilateral oophorectomy, bilateral salpingo-oophorectomy, or vasectomy). A male subject refrains from donating sperm during the study period and for 3 months after the study.
- Signed informed consent form.
Key exclusion criteria (16 listed)
- Female subjects who are pregnant or lactating.
- History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, renal, or other major disease, as determined by the investigator.
- Surgery history within six months before signing the informed consent;
- Allergic history to more than one drug or other serious allergic history.
- Any other abnormal findings on vital signs
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 |
|---|---|---|
| FE-SYHA1402 100mgin either a fasted state or with a meal | Drug | Food effect |
| SYHA1402-25mgSYHA1402 25mg, oral tablets | Drug | Multiple doses 25mg |
| Placebo-25mgMatching placebo tablets | Drug | Multiple doses 25mg |
| SYHA1402-50mgSYHA1402 50mg, oral tablets | Drug | Multiple doses 50mg |
| Placebo-50mgMatching placebo tablets | Drug | Multiple doses 50mg |
| SYHA1402-150mgSYHA1402 150mg, oral tablets | Drug | Multiple doses 150mg |
| Placebo-150mgMatching placebo tablets | Drug | Multiple doses 150mg |
Primary outcome
Effect of food on the pharmacokinetic(Cmax）
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).
Effect of food on the pharmacokinetic(AUC0-inf）
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).
Effect of food on the pharmacokinetic(AUC0-t）
Time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).
Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).
Time frame: up to 5 days after the last dose
incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
12 secondary outcomes
Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)
Time frame: up to 4 days after the last dose
AUC0-t(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
AUC0-inf(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Cmax(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Tmax(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
t1/2z(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
CL/F(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Vz/F(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Rac(AUC)(Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Rac(Cmax) (Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on Cmax (Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
The assessment of the dose-proportionality based on AUC (Part2)
Time frame: Predose and multiple timepoints up to 24 hours after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FE-SYHA1402 100mg, SYHA1402-25mg and SYHA1402-50mg in people with Diabetic Peripheral Neuropathy, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Liu (0311-67808817, liuyanping@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of food on the pharmacokinetic(Cmax） (time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions). The study lists 4 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 1 Jul 2020.