The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject
NCT ID: NCT05737576
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2023-03-20
2023-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort 1
HR011408 injection + NovoRapid®
HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
Cohort 2
NovoRapid® + HR011408 injection
NovoRapid®；HR011408 injection
NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
Cohort 3
HR011408 injection + NovoRapid®
HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.
Cohort 4
NovoRapid® + HR011408 injection
NovoRapid®；HR011408 injection
NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.
Cohort 5
HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.
Cohort 6
HR011408 injection; NovoRapid®
NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Interventions
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HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
NovoRapid®；HR011408 injection
NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.
NovoRapid®；HR011408 injection
NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.
HR011408 injection; NovoRapid®
HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.
HR011408 injection; NovoRapid®
NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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HR011408-102
Identifier Type: -
Identifier Source: org_study_id
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