Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719961
• Other study ID #: HR20014-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 5, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: January 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Sheng Feng
• Phone: +86-0518-82342973
• Email: sheng.feng[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• INS062 injection
Part I: A single dose of 1.2noml/kg is administered.
• Insulin Aspart
Part I: A single dose of 0.2U/kg is administered.
• HR20014 injection
Part II: Ascending single doses at three dose levels
• Insulin Aspart 30 Injection
Part II: A single dosewas administered

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (Part I)	Linear Up Log Down	0 to 10 hours after dosing
Primary	Maximum concentration(Part I)	Observed value	0 to 10 hours after dosing
Primary	Area under the Glucose Infusion Rate (GIR) - time curve (Part I)	Based on smoothed data	0 to 10 hours after dosing
Primary	Maximum GIR (Part I)	Based on smoothed data	0 to 10 hours after dosing
Primary	Area under the Glucose Infusion Rate (GIR) - time curve (Part II)	Based on smoothed data	0h to 24 hours after dosing
Primary	Maximum GIR(Part II)	Based on smoothed data	0 to 24 hours after dosing
Primary	Time to maximum GIR (Part II)	Based on smoothed data	0 to 24 hours after dosing
Primary	Area under the concentration-time curve (Part II)	Linear Up Log Down	0 to 120 hours after dosing
Primary	Maximum concentration(Part II)	Observed value	0 to 120 hours after dosing
Primary	Time to maximum concentration (Part II)	Observed value	0 to 120 hours after dosing
Secondary	Time to maximum concentration (Part I)	Observed value	0 to 10 hours after dosing
Secondary	Terminal half-life (Part I)	Terminal half-life of insulin aspart	0 to 10 hours after dosing
Secondary	Time to maximum GIR (Part I)	Based on smoothed data	0 to 10 hours after dosing
Secondary	Incidence of anti-drug antibody (ADA)(Part I)	Incidence of ADA for insulin aspart	from 0 hour after dosing to 3-14 days after the last dose
Secondary	Incidence and severity of adverse events (AEs)(Part I)	The safety of test drug will be assessed	from screening to 3-14 days after the last dose
Secondary	Incidence of anti-drug antibody (ADA)(Part II)		from 0 hour to 7-21 days after the last dose
Secondary	Incidence and severity of adverse events (AEs)(Part II)	The safety of test drug will be assessed	from screening to 7-21 days after the last dose