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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737576
• Other study ID #: HR011408-102
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2023
• Est. completion date: December 8, 2023

Study information

• Verified date: February 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 8, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC0-0.5h)	Area under the concentration-time curve (AUC)	from 0 to 30 minutes after dose administration
Secondary	Area under the concentration-time curve (AUC0-15min)		from 0 to 15 minutes after dose administration
Secondary	Area under the concentration-time curve (AUC0-1h)		from 0 to 1 hour after dose administration
Secondary	Area under the concentration-time curve (AUC0-1.5h)		from 0 to 1.5 hours after dose administration
Secondary	Area under the concentration-time curve (AUC0-2h)		from 0 to 2 hours after dose administration
Secondary	Area under the concentration-time curve (AUC0-10h)		from 0 to 10 hours after dose administration
Secondary	Area under the concentration-time curve (AUC0-inf)		from 0 to infinity after dose administration
Secondary	Onset of appearance	First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)	from 0 to 8 hours after dose administration
Secondary	Time to 50% maximum observed concentration (time to 50% Cmax)		from 0 to 8 hours after dose administration
Secondary	Time to maximum observed concentration (Tmax)		from 0 to 8 hours after dose administration
Secondary	Maximum observed concentration (Cmax)		from 0 to 8 hours after dose administration
Secondary	Elimination half-life (t1/2)		from 0 to 8 hours after dose administration
Secondary	Area under the GIR-time curve (AUC)	Area under the GIR-time curve (AUC0-10h)	from 0 to 10 hours after dose administration
Secondary	Time to 50% maximum observed GIR(time to 50% GIRmax)		from 0 to 10 hours after dose administration
Secondary	Time to maximum observed GIR (GIRmax)		from 0 to 10 hours after dose administration
Secondary	Incidence and severity of adverse events (AEs)		from Day1 to Day14 after dose administration