Clinical trial NCT05492630: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Nephropathy
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 19 days
measure: Cmax
timeFrame: Day 1-17
measure: AUC0-∞
timeFrame: Day 1-17
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: