The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: NovoRapid®；HR011408 injection; Drug: HR011408 injection; NovoRapid®

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737576

HR011408-102

Details and patient eligibility

About

The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.

Enrollment: 61 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Informed consent obtained prior to any trial-related activities；
2. Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent；
3. Body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (BMI) between 18.0 and 26.0 kg/m2 (both ends included)；
4. Are nonsmokers, have not smoked for at least 6 months before entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or not use smokeless tobacco or nicotine products for the duration of the study.

Exclusion criteria

1. Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator;
2. have a significant history of the circulatory system, respiratory system, digestive system, urinary system, hematopoietic system, endocrine and metabolic system, neuropsychiatric system, musculoskeletal system, or existing diseases in the above systems may affect the safety of the subjects and interfere with the study data.
3. In the opinion of the investigator, are unsuitable for inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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61 participants in 6 patient groups

Cohort 1

Experimental group

Description:

HR011408 injection + NovoRapid®

Treatment:

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Cohort 2

Experimental group

Description:

NovoRapid® + HR011408 injection

Treatment:

Drug: NovoRapid®；HR011408 injection

Drug: NovoRapid®；HR011408 injection

Cohort 3

Experimental group

Description:

HR011408 injection + NovoRapid®

Treatment:

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Cohort 4

Experimental group

Description:

NovoRapid® + HR011408 injection

Treatment:

Drug: NovoRapid®；HR011408 injection

Drug: NovoRapid®；HR011408 injection

Cohort 5

Experimental group

Treatment:

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Cohort 6

Experimental group

Treatment:

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®

Drug: HR011408 injection; NovoRapid®