We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05492630
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: HEC73077 tablets Drug: HEC73077 placebo tablets Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.


Placebo Comparator: 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.
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.





Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 19 days ]
    Incidence of adverse events

  2. Cmax [ Time Frame: Day 1-17 ]
    Maximum plasma concentration of study drugs

  3. AUC0-∞ [ Time Frame: Day 1-17 ]
    area under the concentration versus time curve (AUC) from time zero to infinity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492630


Contacts
Layout table for location contacts
Contact: Yanhua Ding, Doctor 0431-88782168 dingyanhua2003@126.com

Locations
Layout table for location information
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Yanhua Ding, Doctor    0431-88782013    dingyanhua2003@126.com   
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Layout table for additonal information
Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05492630    
Other Study ID Numbers: HEC73077-P-01
First Posted: August 8, 2022    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases