A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects

Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04453618
• Other study ID #: HA1403-CSP-002;V1.0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Yanping Liu
• Phone: 0311-67808817
• Email: liuyanping[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy male or female subjects aged 18 to 45 years (inclusive).

2. 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.

3. With no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests.

4. 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.

5. Signed informed consent form.

Exclusion Criteria:

1. Female subjects who are pregnant or lactating.

2. 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.

3. Surgery history within six months before signing the informed consent;

4. Allergic history to more than one drug or other serious allergic history.

5. Any other abnormal findings on vital signs

6. 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;

7. 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.

8. 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.

9. Alcohol abuse or positive test for alcohol screening.

10. Smoker.

11. History or clinical evidence of drug abuse within the one years before screening, or positive test for drug abuse at screening.

12. 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

13. 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.

14. Have a surgical schedule or a plan on excessive physical activity during the study period.

15. Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;

16. Not suitable for this trial as determined by the investigator.

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• FE-SYHA1402 100mg
in either a fasted state or with a meal
• SYHA1402-25mg
SYHA1402 25mg, oral tablets
• Placebo-25mg
Matching placebo tablets
• SYHA1402-50mg
SYHA1402 50mg, oral tablets
• Placebo-50mg
Matching placebo tablets
• SYHA1402-150mg
SYHA1402 150mg, oral tablets
• Placebo-150mg
Matching placebo tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Primary	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).	Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Primary	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).	Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
Primary	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	up to 5 days after the last dose
Secondary	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	up to 4 days after the last dose
Secondary	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	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	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	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	Cmax(Part2)	Rate and Extent of Absorption SYHA1402 by Assessment of the maximum measured concentration of the analyte in plasma	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	Tmax(Part2)	Rate and Extent of Absorption SYHA1402 by Assessment of the Time to Reach Maximum Observed Concentration	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	t1/2z(Part2)	Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Terminal Elimination Half-life	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	CL/F(Part2)	Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	Vz/F(Part2)	Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	Rac(AUC)(Part2)	Rate and Extent of Absorption of SYHA1402 by Assessment of the Accumulation Ratio	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	Rac(Cmax) (Part2)	Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	The assessment of the dose-proportionality based on Cmax (Part2)	The assessment of the dose-proportionality in the plasma pharmacokinetics (Cmax) of SYHA1402	Predose and multiple timepoints up to 24 hours after the last dose
Secondary	The assessment of the dose-proportionality based on AUC (Part2)	The assessment of the dose-proportionality in the plasma pharmacokinetics (AUC) of SYHA1402	Predose and multiple timepoints up to 24 hours after the last dose