CClinicalTrials.gg
Sign In
CompletedNCT05737576Updated Feb 7, 2024

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

A Phase 1 interventional study of HR011408 injection; NovoRapid® and NovoRapid®；HR011408 injection in Diabetes, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Cohort 1

    HR011408 injection + NovoRapid®

    Drug: HR011408 injection; NovoRapid®

  • Experimental
    Cohort 2

    NovoRapid® + HR011408 injection

    Drug: NovoRapid®；HR011408 injection

  • Experimental
    Cohort 3

    HR011408 injection + NovoRapid®

    Drug: HR011408 injection; NovoRapid®

  • Experimental
    Cohort 4

    NovoRapid® + HR011408 injection

    Drug: NovoRapid®；HR011408 injection

  • Experimental
    Cohort 5

    Drug: HR011408 injection; NovoRapid®

  • Experimental
    Cohort 6

    Drug: HR011408 injection; NovoRapid®

Interventions

  • DrugHR011408 injection; NovoRapid®

    HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.

  • DrugNovoRapid®；HR011408 injection

    NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.

  • DrugHR011408 injection; NovoRapid®

    HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.

  • DrugNovoRapid®；HR011408 injection

    NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.

  • DrugHR011408 injection; NovoRapid®

    HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.

  • DrugHR011408 injection; NovoRapid®

    NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve (AUC0-0.5h)

    Area under the concentration-time curve (AUC)

    Time frame: from 0 to 30 minutes after dose administration

Secondary outcomes

  1. Area under the concentration-time curve (AUC0-15min)

    Time frame: from 0 to 15 minutes after dose administration

  2. Area under the concentration-time curve (AUC0-1h)

    Time frame: from 0 to 1 hour after dose administration

  3. Area under the concentration-time curve (AUC0-1.5h)

    Time frame: from 0 to 1.5 hours after dose administration

  4. Area under the concentration-time curve (AUC0-2h)

    Time frame: from 0 to 2 hours after dose administration

  5. Area under the concentration-time curve (AUC0-10h)

    Time frame: from 0 to 10 hours after dose administration

  6. Area under the concentration-time curve (AUC0-inf)

    Time frame: from 0 to infinity after dose administration

  7. Onset of appearance

    First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)

    Time frame: from 0 to 8 hours after dose administration

  8. Time to 50% maximum observed concentration (time to 50% Cmax)

    Time frame: from 0 to 8 hours after dose administration

  9. Time to maximum observed concentration (Tmax)

    Time frame: from 0 to 8 hours after dose administration

  10. Maximum observed concentration (Cmax)

    Time frame: from 0 to 8 hours after dose administration

  11. Elimination half-life (t1/2)

    Time frame: from 0 to 8 hours after dose administration

  12. Area under the GIR-time curve (AUC)

    Area under the GIR-time curve (AUC0-10h)

    Time frame: from 0 to 10 hours after dose administration

  13. Time to 50% maximum observed GIR(time to 50% GIRmax)

    Time frame: from 0 to 10 hours after dose administration

  14. Time to maximum observed GIR (GIRmax)

    Time frame: from 0 to 10 hours after dose administration

  15. Incidence and severity of adverse events (AEs)

    Time frame: from Day1 to Day14 after dose administration

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05737576
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Mar 20, 2023
Primary completion
Oct 26, 2023
Completion
Dec 8, 2023
Last update
Feb 7, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion