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

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Diabetes

Treatments: Drug: INS062 injection; Drug: HR20014 injection; Drug: Insulin Aspart 30 Injection; Drug: Insulin Aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT05719961

HR20014-101

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups

INS062

Experimental group

Treatment:

Drug: INS062 injection

NovoRapid ®

Active Comparator group

Treatment:

Drug: Insulin Aspart

HR20014

Experimental group

Treatment:

Drug: HR20014 injection

BIAsp 30

Active Comparator group

Treatment:

Drug: Insulin Aspart 30 Injection