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

Diabetic Nephropathy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Randomized, Open-label, Food Effect Study of HEC73077 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492630
• Other study ID #: HEC73077-P-01
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2021
• Est. completion date: January 4, 2023

Study information

• Verified date: April 2023
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of adverse events	Up to 19 days
Primary	Cmax	Maximum plasma concentration of study drugs	Day 1-17
Primary	AUC0-8	area under the concentration versus time curve (AUC) from time zero to infinity	Day 1-17