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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: HR011408 injection; NovoRapid®; Drug: HR011408 injection; NovoRapid®; Drug: NovoRapid®；HR011408 injection; Drug: NovoRapid®；HR011408 injection; Drug: HR011408 injection; NovoRapid®; Drug: HR011408 injection; NovoRapid®

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Feng; Phone Number: 0518-82342973; Email: sheng.feng@hengrui.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 5	Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.; Drug: HR011408 injection; NovoRapid®; NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Experimental: Cohort 6	Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.; Drug: HR011408 injection; NovoRapid®; NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Experimental: Cohort 1; HR011408 injection + NovoRapid®	Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.; Drug: HR011408 injection; NovoRapid®; NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Experimental: Cohort 2; NovoRapid® + HR011408 injection	Drug: NovoRapid®；HR011408 injection; NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.; Drug: NovoRapid®；HR011408 injection; NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.
Experimental: Cohort 3; HR011408 injection + NovoRapid®	Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.; Drug: HR011408 injection; NovoRapid®; HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.; Drug: HR011408 injection; NovoRapid®; NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Experimental: Cohort 4; NovoRapid® + HR011408 injection	Drug: NovoRapid®；HR011408 injection; NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.; Drug: NovoRapid®；HR011408 injection; NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)	from 0 to 8 hours after dose administration
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)	Area under the GIR-time curve (AUC0-10h)	from 0 to 10 hours after dose administration
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: HR011408-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No