NCT05737576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Mar 2023

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 12, 2023

Last Update Submit

February 5, 2024

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (6)

Cohort 1

EXPERIMENTAL

HR011408 injection + NovoRapid®

Drug: HR011408 injection; NovoRapid®

Cohort 2

EXPERIMENTAL

NovoRapid® + HR011408 injection

Drug: NovoRapid®；HR011408 injection

Cohort 3

EXPERIMENTAL

HR011408 injection + NovoRapid®

Drug: HR011408 injection; NovoRapid®

Cohort 4

EXPERIMENTAL

NovoRapid® + HR011408 injection

Drug: NovoRapid®；HR011408 injection

Cohort 5

EXPERIMENTAL
Drug: HR011408 injection; NovoRapid®

Cohort 6

EXPERIMENTAL
Drug: HR011408 injection; NovoRapid®

Interventions

HR011408 injection; NovoRapid®DRUG

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

Cohort 1
NovoRapid®；HR011408 injectionDRUG

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

Cohort 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assigned to HR011408 or NovoRapid®
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 21, 2023

Study Start

March 20, 2023

Primary Completion

October 26, 2023

Study Completion

December 8, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CN(1)