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

Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Drug: INS062 injection; Drug: Insulin Aspart; Drug: HR20014 injection; Drug: Insulin Aspart 30 Injection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Feng; Phone Number: +86-0518-82342973; Email: sheng.feng@hengrui.com
• Study Contact Backup: Name: Hong Chen; Phone Number: +86-0518-82342973; Email: hong.chen@hengrui.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: BIAsp 30	Drug: Insulin Aspart 30 Injection; Part II: A single dosewas administered
EXPERIMENTAL: INS062	Drug: INS062 injection; Part I: A single dose of 1.2noml/kg is administered.
ACTIVE_COMPARATOR: NovoRapid ®	Drug: Insulin Aspart; Part I: A single dose of 0.2U/kg is administered.
EXPERIMENTAL: HR20014	Drug: HR20014 injection; Part II: Ascending single doses at three dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve （Part I）	Linear Up Log Down	0 to 10 hours after dosing
Maximum concentration（Part I）	Observed value	0 to 10 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve （Part I）	Based on smoothed data	0 to 10 hours after dosing
Maximum GIR （Part I）	Based on smoothed data	0 to 10 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve （Part II）	Based on smoothed data	0h to 24 hours after dosing
Maximum GIR（Part II）	Based on smoothed data	0 to 24 hours after dosing
Time to maximum GIR （Part II）	Based on smoothed data	0 to 24 hours after dosing
Area under the concentration-time curve （Part II）	Linear Up Log Down	0 to 120 hours after dosing
Maximum concentration（Part II）	Observed value	0 to 120 hours after dosing
Time to maximum concentration （Part II）	Observed value	0 to 120 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum concentration （Part I）	Observed value	0 to 10 hours after dosing
Terminal half-life （Part I）	Terminal half-life of insulin aspart	0 to 10 hours after dosing
Time to maximum GIR （Part I）	Based on smoothed data	0 to 10 hours after dosing
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
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
Incidence of anti-drug antibody (ADA)（Part II）		from 0 hour to 7-21 days after the last dose
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2023
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 30, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: HR20014-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No