Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects
Phase 1
Recruiting
- Conditions
- Diabetes
- Interventions
- Registration Number
- NCT05719961
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male subjects aged 18 ~ 45 (including the boundary. value)(Part I). Subjects aged 18 ~ 45 (including the boundary value), male or female(Part II).
- 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
- Body Mass Index (BMI) between 18.0-26.0 kg/m2 (both inclusive).
Exclusion Criteria
- A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug.
- Have a history of hypertension.
- Severe systemic infectious diseases within 1 month before screening.
- 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.
- Presence of any abnormal and clinically significant laboratory tests.
- 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
- Known or suspected history of drug abuse or positive urine drug screening test within screening period.
- 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;
- Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIAsp 30 Insulin Aspart 30 Injection - INS062 INS062 injection - HR20014 HR20014 injection - NovoRapid ® Insulin Aspart -
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve （Part II） 0 to 120 hours after dosing Linear Up Log Down
Area under the Glucose Infusion Rate (GIR) - time curve （Part II） 0h to 24 hours after dosing Based on smoothed data
Maximum concentration（Part II） 0 to 120 hours after dosing Observed value
Area under the Glucose Infusion Rate (GIR) - time curve （Part I） 0 to 10 hours after dosing Based on smoothed data
Area under the concentration-time curve （Part I） 0 to 10 hours after dosing Linear Up Log Down
Maximum concentration（Part I） 0 to 10 hours after dosing Observed value
Maximum GIR （Part I） 0 to 10 hours after dosing Based on smoothed data
Maximum GIR（Part II） 0 to 24 hours after dosing Based on smoothed data
Time to maximum concentration （Part II） 0 to 120 hours after dosing Observed value
Time to maximum GIR （Part II） 0 to 24 hours after dosing Based on smoothed data
- Secondary Outcome Measures
Name Time Method Terminal half-life （Part I） 0 to 10 hours after dosing Terminal half-life of insulin aspart
Incidence of anti-drug antibody (ADA)（Part I） from 0 hour after dosing to 3-14 days after the last dose Incidence of ADA for insulin aspart
Time to maximum concentration （Part I） 0 to 10 hours after dosing Observed value
Incidence of anti-drug antibody (ADA)（Part II） from 0 hour to 7-21 days after the last dose Time to maximum GIR （Part I） 0 to 10 hours after dosing Based on smoothed data
Incidence and severity of adverse events (AEs)（Part I） from screening to 3-14 days after the last dose The safety of test drug will be assessed
Incidence and severity of adverse events (AEs)（Part II） from screening to 7-21 days after the last dose The safety of test drug will be assessed
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China