DiabetesPhase 1NCT05887895

To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects

A Phase 1 study testing INS062 injection、INS068 injection、HR20014 injection in people with Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes
What is being tested?: INS062 injection、INS068 injection、HR20014 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 23 May 2023to 18 Jul 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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able and willing to provide a written informed consent;
Male or female aged 18-45 at screening (both inclusive);
Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator;
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in 18.0~26.0 kg/m2 (both inclusive);
During the screening phase oral glucose tolerance test (OGTT), intravenous fasting plasma glucose ≥3.9 mmol/L and < 6.1 mmol/L; Glucose 2 hours after negative charge static pulse blood sugar <7.8mmol/L； and normal or abnormal insulin levels have no clinical significance.

Who cannot join

A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug;
Have a history of hypertension;
Severe systemic infectious diseases within 1 month before screening;
Patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis;
Patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this study;
Use of prescription drugs (topical eye/nasal drops and creams and occasional antipyretic and analgesic drugs such as acetaminophen within recommended doses are permitted) and over-the-counter drugs, and Chinese herbal medicine (regular vitamins are allowed) within 2 weeks before screening;

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Presence of any abnormal and clinically significant laboratory tests.
ECG (12-lead electrocardiogram) showed abnormal and clinically significant.
Those who have participated in any drug clinical trials within 3 months or 5 half-life periods before screening (the elder shall prevail), who participated in clinical trials are defined as random, prior to screening.
Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood ≥400 mL in the 3 months prior to screening.
Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential (WOCBP) are reluctant to use appropriate contraception during the trial.
The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The second affiliated hospital of Anhui Medical University
Hefei, Anhui, 230601

Other trials in China

About this study

Official title: A Trial Comparing the Pharmacodynamics and Pharmacokinetics of HR20014, INS068 and INS062 in Healthy Subjects

This is a single-center, randomized, open, six-sequence, three-period crossover phase I clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection were given subcutaneously three times before and after each sequence.

Conditions: Diabetes
Being tested: INS062 injection、INS068 injection、HR20014 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.

INS062 injection、INS068 injection、HR20014 injectionDrug
INS062 injection：A single dose of 0.4 DU/kg is administered to healthy subjects.
INS068 injection：A single dose of 0.4 U/kg is administered to healthy subjects.
HR20014 injection：A single dose of 0.4 U/kg is administered to healthy subjects.

Study groups in NCT05887895
Study group	Role	What they receive
Treatment group sequence 1	Experimental	Subjects were given HR20014, INS068, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection
Treatment group sequence 2	Experimental	Subjects were given HR20014, INS062, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection
Treatment group sequence 3	Experimental	Subjects were given INS068, HR20014, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection
Treatment group sequence 4	Experimental	Subjects were given INS068, INS062, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection
Treatment group sequence 5	Experimental	Subjects were given INS062, HR20014, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection
Treatment group sequence 6	Experimental	Subjects were given INS062, INS068, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. Receives: Drug: INS062 injection、INS068 injection、HR20014 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068）
Measured: 0 hour to 6 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS062）
Measured: 6 hours to 24 hours after dosing

Secondary outcomes (5)

Area under the Glucose Infusion Rate (GIR) - time curve
Based on the absolute dose and concentration of INS068
Measured: 0 hour to 96 hours after dosing
Maximum concentration of INS068
Based on the absolute dose and concentration of INS068
Measured: 0 hour to 96 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve
Based on the absolute dose and concentration of INS062
Measured: 0 hour to 10 hours after dosing
Maximum concentration of INS062
Based on the absolute dose and concentration of INS062
Measured: 0 hour to 10 hours after dosing
Incidence and severity of adverse events (AEs)
Measured: from screening to 7-21 days after the last dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202318 Jul 2023

First posted5 Jun 2023
Study start23 May 2023
Primary completion18 Jul 2023
Study completion18 Jul 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: The study was a single-center, randomized, open, six-sequence, three-cycle crossover phase I study in healthy subjects. The objective of this trial was to compare the PK/PD and safety of HR20014, INS068 and INS062 in a single subcutaneous injection of the same dose.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05887895
Sponsor's protocol ID: HR20014-102
Status last verified: Jul 2023
First submitted: 8 May 2023
Last updated: 20 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Comparing the Pharmacodynamics and Pharmacokinetics of HR20014, INS068 and INS062 in Healthy Subjects
ClinicalTrials.gov ID: NCT05887895
Acronym / sponsor ID: HR20014-102
Conditions: Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 May 2023 (actual)
Primary completion: 18 Jul 2023 (actual)
Study completion: 18 Jul 2023 (actual)
First posted: 5 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: The study was a single-center, randomized, open, six-sequence, three-cycle crossover phase I study in healthy subjects. The objective of this trial was to compare the PK/PD and safety of HR20014, INS068 and INS062 in a single subcutaneous injection of the same dose.

Arm	Type	Receives
Treatment group sequence 1	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given HR20014, INS068, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
Treatment group sequence 2	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given HR20014, INS062, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
Treatment group sequence 3	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given INS068, HR20014, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
Treatment group sequence 4	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given INS068, INS062, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
Treatment group sequence 5	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given INS062, HR20014, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.
Treatment group sequence 6	Experimental	Drug: INS062 injection、INS068 injection、HR20014 injectionSubjects were given INS062, INS068, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Able and willing to provide a written informed consent;
Male or female aged 18-45 at screening (both inclusive);
Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator;
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in 18.0~26.0 kg/m2 (both inclusive);
During the screening phase oral glucose tolerance test (OGTT), intravenous fasting plasma glucose ≥3.9 mmol/L and < 6.1 mmol/L; Glucose 2 hours after negative charge static pulse blood sugar <7.8mmol/L； and normal or abnormal insulin levels have no clinical significance.

Key exclusion criteria (12 listed)

A history of recurrent or severe drug food allergy, or known or suspected allergy to any component of the study drug;
Have a history of hypertension;
Severe systemic infectious diseases within 1 month before screening;
Patients with a history of lower extremity deep vein thrombosis or high risk of lower extremity deep vein thrombosis;
Patients with serious diseases of the psychiatric, cardiovascular, respiratory, digestive, endocrine, blood, urogenital and other systems in the past, or existing diseases of the above systems, were judged by the researchers to be unfit to participate in this 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
INS062 injection、INS068 injection、HR20014 injectionINS062 injection：A single dose of 0.4 DU/kg is administered to healthy subjects. INS068 injection：A single dose of 0.4 U/kg is administered to healthy subjects. HR20014 injection：A single dose of 0.4 U/kg is administered to healthy subjects.	Drug	Treatment group sequence 1, Treatment group sequence 2, Treatment group sequence 3, Treatment group sequence 4, Treatment group sequence 5, Treatment group sequence 6

Primary outcome

Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068）
Time frame: 0 hour to 6 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS062）
Time frame: 6 hours to 24 hours after dosing

5 secondary outcomes

Area under the Glucose Infusion Rate (GIR) - time curve
Time frame: 0 hour to 96 hours after dosing
Maximum concentration of INS068
Time frame: 0 hour to 96 hours after dosing
Area under the Glucose Infusion Rate (GIR) - time curve
Time frame: 0 hour to 10 hours after dosing
Maximum concentration of INS062
Time frame: 0 hour to 10 hours after dosing
Incidence and severity of adverse events (AEs)
Time frame: from screening to 7-21 days after the last dosing

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 20 Jul 2023.
Individual participant dataSharing planned: Undecided

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 INS062 injection、INS068 injection、HR20014 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 5 inclusion and 12 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 20 Jul 2023. 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 Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068） (time frame: 0 hour to 6 hours after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887895.

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 20 Jul 2023.