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

NCT05719961 | Unknown Phase 1

• 1 other identifier: HR20014-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• Time to maximum concentration （Part I）

  0 to 10 hours after dosing

• Terminal half-life （Part I）

  0 to 10 hours after dosing

• Time to maximum GIR （Part I）

  0 to 10 hours after dosing

• Incidence of anti-drug antibody (ADA)（Part I）

  from 0 hour after dosing to 3-14 days after the last dose

• Incidence and severity of adverse events (AEs)（Part I）

  from screening to 3-14 days after the last dose

Study Arms (4)

INS062

EXPERIMENTAL

Drug: INS062 injection

NovoRapid ®

ACTIVE COMPARATOR

Drug: Insulin Aspart

HR20014

EXPERIMENTAL

Drug: HR20014 injection

BIAsp 30

ACTIVE COMPARATOR

Drug: Insulin Aspart 30 Injection

Interventions

INS062 injection DRUG

Part I: A single dose of 1.2noml/kg is administered.

INS062

Insulin Aspart DRUG

Part I: A single dose of 0.2U/kg is administered.

NovoRapid ®

HR20014 injection DRUG

Part II: Ascending single doses at three dose levels

HR20014

Insulin Aspart 30 Injection DRUG

Part II: A single dosewas administered

BIAsp 30

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Sheng Feng

CONTACT

+86-0518-82342973; sheng.feng@hengrui.com

Hong Chen

CONTACT

+86-0518-82342973; hong.chen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 9, 2023
• Study Start: January 5, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 30, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-01

Locations

CN (1)