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

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HEC73077 tablets

HEC73077 placebo tablets

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
Be able to complete the study according to the trail protocol.
Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
subjects and must be 18 to 45 years of age inclusive.
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.
There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening.
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:

Use of >5 cigarettes per day during the past 3 months.
Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 14 units/week).
Positive results from urine drug screen test.
Donation or loss of blood over 450 mL within 3 months prior to screening.
Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening.
Use of any prescription or non-prescription medications within 14 days prior to initial dosing
Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
Subjects who participated in another clinical trial within 3 months prior to initial dosing.
Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
Subjects deemed unsuitable by the investigator for any other reason.

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HEC73077 tablets

HEC73077 placebo tablets

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse Events

Incidence of adverse events

Cmax

Maximum plasma concentration of study drugs

AUC0-∞

area under the concentration versus time curve (AUC) from time zero to infinity

Secondary Outcome Measures

Full Information

NCT ID

NCT05492630

First Posted

August 5, 2022

Last Updated

April 11, 2023

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05492630

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 24, 2021 (Actual)

Primary Completion Date

January 4, 2023 (Actual)

Study Completion Date

January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HEC73077 tablets

Arm Type

Experimental

Arm Description

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

Arm Title

HEC73077 placebo tablets

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HEC73077 tablets

Intervention Description

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

Intervention Name(s)

HEC73077 placebo tablets

Intervention Description

Primary Outcome Measure Information:

Title

Adverse Events

Description

Incidence of adverse events

Time Frame

Up to 19 days

Title

Cmax

Description

Maximum plasma concentration of study drugs

Time Frame

Day 1-17

Title

AUC0-∞

Description

area under the concentration versus time curve (AUC) from time zero to infinity

Time Frame

Day 1-17

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. Be able to complete the study according to the trail protocol. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures. subjects and must be 18 to 45 years of age inclusive. 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. There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening. 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: Use of >5 cigarettes per day during the past 3 months. Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies). History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 14 units/week). Positive results from urine drug screen test. Donation or loss of blood over 450 mL within 3 months prior to screening. Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening. Use of any prescription or non-prescription medications within 14 days prior to initial dosing Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. Subjects who participated in another clinical trial within 3 months prior to initial dosing. Female subjects were lactating or had positive serum pregnancy results during the screening or testing period. Subjects deemed unsuitable by the investigator for any other reason.

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

12. IPD Sharing Statement

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

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