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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 1

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Placebo-50mg; Drug: Placebo-25mg; Drug: Placebo-150mg; Drug: SYHA1402-50mg; Drug: SYHA1402-150mg; Drug: SYHA1402-25mg; Drug: FE-SYHA1402 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04453618

HA1403-CSP-002；V1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 4 patient groups

Food effect

Experimental group

Description:

Healthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal.

Treatment:

Drug: FE-SYHA1402 100mg

Multiple doses 25mg

Experimental group

Description:

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）.

Treatment:

Drug: Placebo-25mg

Drug: SYHA1402-25mg

Multiple doses 50mg

Experimental group

Description:

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）.

Treatment:

Drug: SYHA1402-50mg

Drug: Placebo-50mg

Multiple doses 150mg

Experimental group

Description:

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）.

Treatment:

Drug: Placebo-150mg

Drug: SYHA1402-150mg