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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05737576

Collaborator

(none)

Enrollment

Arms

3.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: HR011408 injection; NovoRapid® Drug: NovoRapid®；HR011408 injection Drug: HR011408 injection; NovoRapid® Drug: NovoRapid®；HR011408 injection	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Crossover Assigned to HR011408 or NovoRapid®Crossover Assigned to HR011408 or NovoRapid®

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Single Center, Randomized, Double-Blind, 2-period, 2-sequence Crossover Designed Study to Evaluate the Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Jun 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 HR011408 injection + NovoRapid®	Drug: HR011408 injection; NovoRapid® HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
Experimental: Cohort 2 NovoRapid® + HR011408 injection	Drug: NovoRapid®；HR011408 injection NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
Experimental: Cohort 3 HR011408 injection + NovoRapid®	Drug: HR011408 injection; NovoRapid® HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.
Experimental: Cohort 4 NovoRapid® + HR011408 injection	Drug: NovoRapid®；HR011408 injection NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.

Outcome Measures

Primary Outcome Measures

Area under the concentration-time curve (AUC0-0.5h) [from 0 to 30 minutes after dose administration]
Area under the concentration-time curve (AUC)

Secondary Outcome Measures

Area under the concentration-time curve (AUC0-15min) [from 0 to 15 minutes after dose administration]
Area under the concentration-time curve (AUC0-1h) [from 0 to 1 hour after dose administration]
Area under the concentration-time curve (AUC0-1.5h) [from 0 to 1.5 hours after dose administration]
Area under the concentration-time curve (AUC0-2h) [from 0 to 2 hours after dose administration]
Area under the concentration-time curve (AUC0-10h) [from 0 to 10 hours after dose administration]
Area under the concentration-time curve (AUC0-inf) [from 0 to infinity after dose administration]
Onset of appearance [from 0 to 8 hours after dose administration]
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Time to 50% maximum observed concentration (time to 50% Cmax) [from 0 to 8 hours after dose administration]
Time to maximum observed concentration (Tmax) [from 0 to 8 hours after dose administration]
Maximum observed concentration (Cmax) [from 0 to 8 hours after dose administration]
Elimination half-life (t1/2) [from 0 to 8 hours after dose administration]
Area under the GIR-time curve (AUC) [from 0 to 10 hours after dose administration]
Area under the GIR-time curve (AUC0-10h)
Time to 50% maximum observed GIR(time to 50% GIRmax) [from 0 to 10 hours after dose administration]
Time to maximum observed GIR (GIRmax) [from 0 to 10 hours after dose administration]
Incidence and severity of adverse events (AEs) [from Day1 to Day14 after dose administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Informed consent obtained prior to any trial-related activities；
Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent；
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)；
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:

Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator;
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.
In the opinion of the investigator, are unsuitable for inclusion in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05737576

Other Study ID Numbers:

HR011408-102

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Insulin Aspart

Insulin, Long-Acting

Insulin degludec, insulin aspart drug combination

Study Results

No Results Posted as of Feb 21, 2023