Clinical trial NCT05719961: Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects
Official title: Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).


Eligibility criteria: Inclusion Criteria:

1. Male subjects aged 18 \~ 45 (including the boundary. value)(Part I). Subjects aged 18 \~ 45 (including the boundary value), male or female(Part II).
2. Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
3. Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).

Exclusion Criteria:

1. A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
2. Have a history of hypertension.
3. Severe systemic infectious diseases within 1 month before screening.
4. Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening.
5. Presence of any abnormal and clinically significant laboratory tests.
6. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
7. Known or suspected history of drug abuse or positive urine drug screening test within screening period.
8. Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (The elder shall prevail), who participated in clinical trials are defined as random, prior to screening;
9. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.

Primary outcomes:
measure: Area under the concentration-time curve （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Maximum concentration（Part I）
timeFrame: 0 to 10 hours after dosing
measure: Area under the Glucose Infusion Rate (GIR) - time curve （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Maximum GIR （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Area under the Glucose Infusion Rate (GIR) - time curve （Part II）
timeFrame: 0h to 24 hours after dosing
measure: Maximum GIR（Part II）
timeFrame: 0 to 24 hours after dosing
measure: Time to maximum GIR （Part II）
timeFrame: 0 to 24 hours after dosing
measure: Area under the concentration-time curve （Part II）
timeFrame: 0 to 120 hours after dosing
measure: Maximum concentration（Part II）
timeFrame: 0 to 120 hours after dosing
measure: Time to maximum concentration （Part II）
timeFrame: 0 to 120 hours after dosing
Secondary outcomes:
measure: Time to maximum concentration （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Terminal half-life （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Time to maximum GIR （Part I）
timeFrame: 0 to 10 hours after dosing
measure: Incidence of anti-drug antibody (ADA)（Part I）
timeFrame: from 0 hour after dosing to 3-14 days after the last dose
measure: Incidence and severity of adverse events (AEs)（Part I）
timeFrame: from screening to 3-14 days after the last dose
measure: Incidence of anti-drug antibody (ADA)（Part II）
timeFrame: from 0 hour to 7-21 days after the last dose
measure: Incidence and severity of adverse events (AEs)（Part II）
timeFrame: from screening to 7-21 days after the last dose
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: