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

Phase 1

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: HEC73077 tablets; Drug: HEC73077 placebo tablets

• Registration Number: NCT05492630
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC73077 tablets	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.
HEC73077 placebo tablets	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 19 days	Incidence of adverse events
Cmax	Day 1-17	Maximum plasma concentration of study drugs
AUC0-∞	Day 1-17	area under the concentration versus time curve (AUC) from time zero to infinity

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China