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

NCT05492630 | Completed Phase 1

• 1 other identifier: HEC73077-P-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Incidence of adverse events

  Up to 19 days

• Cmax

  Maximum plasma concentration of study drugs

  Day 1-17

• AUC0-∞

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

  Day 1-17

Study Arms (2)

HEC73077 tablets

EXPERIMENTAL

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

Drug: HEC73077 tablets

HEC73077 placebo tablets

PLACEBO COMPARATOR

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

Drug: HEC73077 placebo tablets

Interventions

HEC73077 tablets 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 tablets

HEC73077 placebo tablets 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: May 24, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)