DiabetesPhase 1NCT05737576
The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject
A Phase 1 study testing HR011408 injection; NovoRapid® and NovoRapid®；HR011408 injection in people with Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- HR011408 injection; NovoRapid® and NovoRapid®；HR011408 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 8 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
- Conditions
- Diabetes
- Being tested
- HR011408 injection; NovoRapid®, NovoRapid®；HR011408 injection
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR011408 injection; NovoRapid®Drug
HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
NovoRapid®；HR011408 injectionDrug
NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
HR011408 injection; NovoRapid®Drug
HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.
NovoRapid®；HR011408 injectionDrug
NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.
HR011408 injection; NovoRapid®Drug
HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.
HR011408 injection; NovoRapid®Drug
NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | HR011408 injection + NovoRapid® Receives: Drug: HR011408 injection; NovoRapid® |
| Cohort 2 | Experimental | NovoRapid® + HR011408 injection Receives: Drug: NovoRapid®；HR011408 injection |
| Cohort 3 | Experimental | HR011408 injection + NovoRapid® Receives: Drug: HR011408 injection; NovoRapid® |
| Cohort 4 | Experimental | NovoRapid® + HR011408 injection Receives: Drug: NovoRapid®；HR011408 injection |
| Cohort 5 | Experimental | Not described Receives: Drug: HR011408 injection; NovoRapid® |
| Cohort 6 | Experimental | Not described Receives: Drug: HR011408 injection; NovoRapid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC0-0.5h)
Area under the concentration-time curve (AUC)
Measured: from 0 to 30 minutes after dose administration
Secondary outcomes (15)
Area under the concentration-time curve (AUC0-15min)
Measured: from 0 to 15 minutes after dose administration
Area under the concentration-time curve (AUC0-1h)
Measured: from 0 to 1 hour after dose administration
Area under the concentration-time curve (AUC0-1.5h)
Measured: from 0 to 1.5 hours after dose administration
Area under the concentration-time curve (AUC0-2h)
Measured: from 0 to 2 hours after dose administration
Area under the concentration-time curve (AUC0-10h)
Measured: from 0 to 10 hours after dose administration
Area under the concentration-time curve (AUC0-inf)
Measured: from 0 to infinity after dose administration
Onset of appearance
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Measured: from 0 to 8 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
Measured: from 0 to 8 hours after dose administration
Time to maximum observed concentration (Tmax)
Measured: from 0 to 8 hours after dose administration
Maximum observed concentration (Cmax)
Measured: from 0 to 8 hours after dose administration
Elimination half-life (t1/2)
Measured: from 0 to 8 hours after dose administration
Area under the GIR-time curve (AUC)
Area under the GIR-time curve (AUC0-10h)
Measured: from 0 to 10 hours after dose administration
Time to 50% maximum observed GIR(time to 50% GIRmax)
Measured: from 0 to 10 hours after dose administration
Time to maximum observed GIR (GIRmax)
Measured: from 0 to 10 hours after dose administration
Incidence and severity of adverse events (AEs)
Measured: from Day1 to Day14 after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start20 Mar 2023
- Primary completion26 Oct 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assigned to HR011408 or NovoRapid®
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737576
- Sponsor's protocol ID
- HR011408-102
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05737576
- Acronym / sponsor ID
- HR011408-102
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Crossover Assigned to HR011408 or NovoRapid®
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HR011408 injection; NovoRapid®HR011408 injection + NovoRapid® |
| Cohort 2 | Experimental | Drug: NovoRapid®；HR011408 injectionNovoRapid® + HR011408 injection |
| Cohort 3 | Experimental | Drug: HR011408 injection; NovoRapid®HR011408 injection + NovoRapid® |
| Cohort 4 | Experimental | Drug: NovoRapid®；HR011408 injectionNovoRapid® + HR011408 injection |
| Cohort 5 | Experimental | Drug: HR011408 injection; NovoRapid® |
| Cohort 6 | Experimental | Drug: HR011408 injection; NovoRapid® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR011408 injection; NovoRapid®HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1. | Drug | Cohort 1 |
| NovoRapid®；HR011408 injectionNovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1. | Drug | Cohort 2 |
| HR011408 injection; NovoRapid®HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2. | Drug | Cohort 3 |
| NovoRapid®；HR011408 injectionNovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2. | Drug | Cohort 4 |
| HR011408 injection; NovoRapid®HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3. | Drug | Cohort 5 |
| HR011408 injection; NovoRapid®NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3. | Drug | Cohort 6 |
Primary outcome
Area under the concentration-time curve (AUC0-0.5h)
Time frame: from 0 to 30 minutes after dose administration
Area under the concentration-time curve (AUC)
15 secondary outcomes
Area under the concentration-time curve (AUC0-15min)
Time frame: from 0 to 15 minutes after dose administration
Area under the concentration-time curve (AUC0-1h)
Time frame: from 0 to 1 hour after dose administration
Area under the concentration-time curve (AUC0-1.5h)
Time frame: from 0 to 1.5 hours after dose administration
Area under the concentration-time curve (AUC0-2h)
Time frame: from 0 to 2 hours after dose administration
Area under the concentration-time curve (AUC0-10h)
Time frame: from 0 to 10 hours after dose administration
Area under the concentration-time curve (AUC0-inf)
Time frame: from 0 to infinity after dose administration
Onset of appearance
Time frame: from 0 to 8 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
Time frame: from 0 to 8 hours after dose administration
Time to maximum observed concentration (Tmax)
Time frame: from 0 to 8 hours after dose administration
Maximum observed concentration (Cmax)
Time frame: from 0 to 8 hours after dose administration
Elimination half-life (t1/2)
Time frame: from 0 to 8 hours after dose administration
Area under the GIR-time curve (AUC)
Time frame: from 0 to 10 hours after dose administration
Time to 50% maximum observed GIR(time to 50% GIRmax)
Time frame: from 0 to 10 hours after dose administration
Time to maximum observed GIR (GIRmax)
Time frame: from 0 to 10 hours after dose administration
Incidence and severity of adverse events (AEs)
Time frame: from Day1 to Day14 after dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR011408 injection; NovoRapid® and NovoRapid®；HR011408 injection in people with Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (AUC0-0.5h) (time frame: from 0 to 30 minutes after dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.