Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects

NCT ID: NCT05492630

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2023-01-04

Brief Summary

The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects

Conditions

Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HEC73077 tablets

Single-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.

Group Type: EXPERIMENTAL

HEC73077 tablets

Intervention Type: DRUG

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

HEC73077 placebo tablets

Single-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.

Group Type: PLACEBO_COMPARATOR

HEC73077 placebo tablets

Intervention Type: DRUG

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

Interventions

HEC73077 tablets

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

Intervention Type: DRUG

HEC73077 placebo tablets

Single-Dose Study: Each dose of HEC73077 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.

2. Be able to complete the study according to the trail protocol.

3. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.

4. subjects and must be 18 to 45 years of age inclusive.

5. Body weight ≥ 45 kg(for female) or ≥ 50 kg(for male) and body mass index（BMI）between 18 and 28 kg / m^2, inclusive, at screening.

6. There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening.

7. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria

1. Use of >5 cigarettes per day during the past 3 months.

2. Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).

3. History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 14 units/week).

4. Positive results from urine drug screen test.

5. Donation or loss of blood over 450 mL within 3 months prior to screening.

6. Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening.

7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing

8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

9. Subjects who participated in another clinical trial within 3 months prior to initial dosing.

10. Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.

11. Subjects deemed unsuitable by the investigator for any other reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HEC73077-P-01

Identifier Type: -

Identifier Source: org_study_id