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

Sponsor
Sunshine Lake Pharma Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05492630
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
20.8
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: HEC73077 tablets
  • Drug: HEC73077 placebo tablets
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [Up to 19 days]

    Incidence of adverse events

  2. Cmax [Day 1-17]

    Maximum plasma concentration of study drugs

  3. AUC0-∞ [Day 1-17]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Hospital of Jilin University Changchun Jilin China 130000

Sponsors and Collaborators

  • Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05492630
Other Study ID Numbers:
  • HEC73077-P-01
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
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:
Diabetic Nephropathies

Study Results

No Results Posted as of Aug 8, 2022