Type 2 DiabetesPhase 1NCT06086912
A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites
A Phase 1 study testing HR17031 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HR17031
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2023to 12 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
- Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.
- Both men and women are eligible, aged 18 to 55 years old (inclusive, as determined at the time of signing informed consent form).
- Body mass index (BMI) is between 18 and 27 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- Fasting blood glucose level < 6.1 mmol/L during screening period.
Who cannot join
- -
- 1. The following laboratory or auxiliary examination abnormalities are present during the screening period:
- Any abnormal laboratory examination with clinical significance. For laboratory examinations with clinical significance, if there is a clear and reasonable reason, retesting can be performed within one week and the retest results used to determine whether the subject meets the criteria;
- Abnormalities on 12-lead electrocardiogram (ECG) with clinical significance;
- Positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C antibody (anti-HCV) (or diagnosed as active hepatitis), or positive for syphilis antibody;
- Positive for human immunodeficiency virus (HIV) serological test.
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- 2. The following diseases or medical history are present:
- History of hypertension, or systolic blood pressure outside the range of 90-140 mmHg or diastolic blood pressure outside the range of 60-90 mmHg during screening, and judged to have clinical significance by the investigator;
- Having a life-threatening disease within the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin);
- Having a severe systemic infection within the past 1 month;
- Having a history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other risk factors for pancreatitis that may be present;
- Having a relevant history of gastrointestinal disease with persistent nausea and vomiting, including but not limited to: having had gastroparesis within the past 6 months that required treatment, unstable (worsening) or poorly controlled (persistent nausea and vomiting) gastroesophageal reflux disease (GERD), or surgery that affects gastric emptying;
- Having a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) with a genetic predisposition;
- Having a history of any clinically significant disease or condition that the investigator believes may affect the trial results, including but not limited to a history of cardiovascular, endocrine, neurological, digestive, urinary, hematological, immunological, metabolic diseases, or existing diseases in these systems.
- 3. Medications (prescription or over-the-counter), food supplements, vitamins, and Chinese herbal medicines used within 2 weeks before the start of treatment are prohibited. Local application of eye/nose drops and ointments are allowed.
- 4. The following conditions are prohibited:
- Known or suspected allergy to any component of the study drug;
- Participated in any clinical trial of drugs or medical devices within the past 3 months (determined by the signing of informed consent form);
- Average daily alcohol intake of more than 15 g within the past week (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol white wine); alcohol consumption or positive results on alcohol breath test within 48 hours before treatment;
- Smokers (at least 5 cigarettes per day) or non-smokers who smoked within 48 hours before treatment (including the use of nicotine replacement products);
- Long-term or within 48 hours before treatment consumption of coffee, tea, chocolate, or soft drinks, such as those containing methylxanthines (theophylline, caffeine, or theobromine) such as cola;
- Engaging in strenuous exercise, such as weightlifting, sprinting, long-distance running, cycling, swimming, or playing soccer, within 48 hours before treatment;
- Known or suspected history of drug abuse or positive urine drug screening test during screening; unable or unwilling to abstain from smoking, nicotine gum, or transdermal nicotine patch during the trial; unwilling to abstain from alcohol during the trial;
- Blood donation within the past month; or blood donation of ≥400 mL within the past 3 months or loss of blood of ≥400 mL due to trauma or major surgery within the past 3 months;
- Participants with mental or language disabilities who are unable to fully understand or participate in the trial process;
- Participants with poor compliance or poor venous access, or those with a history of fainting;
- Pregnant or breastfeeding women;
- Participants with the ability to reproduce who have plans to conceive within 10 weeks after the last dose of the study drug or refuse to use medically approved contraception (contraception methods are listed in Appendix 1).
- 5. Any other condition judged by the investigator to interfere with the evaluation of the trial results or to be inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100032
About this study
Official title: A Single-center, Randomized, Open, Three-period, Three-sequence Crossover Clinical Study to Compare the Bioavailability and Safety of a Single Subcutaneous Injection of HR17031 in Healthy Subjects at Different Sites
The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites.
- Conditions
- Type 2 Diabetes
- Being tested
- HR17031
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR17031Drug
Receive a single dose of HR17031 at every period (First period：abdomen. Second period. upper arm. Third period: thigh).
HR17031Drug
Receive a single dose of HR17031 at every period (First period：upper arm. Second period: thigh. Third period: abdomen).
HR17031Drug
Receive a single dose of HR17031 at every period (First period：thigh. Second period: abdomen. Third period: upper arm).
| Study group | Role | What they receive |
|---|---|---|
| sequence 1 | Experimental | Not described Receives: Drug: HR17031 |
| sequence 2 | Experimental | Not described Receives: Drug: HR17031 |
| sequence 3 | Experimental | Not described Receives: Drug: HR17031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-t)
Measured: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-∞)
Measured: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Maximum Concentration (Cmax)
Measured: Start of treatment up to Day 26
Secondary outcomes (7)
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Time to maximum concentration (Tmax)
Measured: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent terminal half-life (t1/2)
Measured: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Clearance (CL/F)
Measured: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent volume of distribution (Vz/F)
Measured: Start of treatment up to Day 26
Safety indicators: Adverse events (AE, including Injection site reactions, Hypoglycemia events, etc.), serious adverse events (SAE).
Measured: Screening period up to Day 26
Immunogenicity indicators: anti-Noiiglutide antibodies
Measured: Start of treatment up to Day 26
Immunogenicity indicators: anti-INS068 antibodies
Measured: Start of treatment up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start7 Nov 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- This study is a single-center, randomized, open-label, three-period, and three-sequence crossover design trial, consisting of three sequences (sequence 1, sequence 2 and sequence 3) and three periods (first period, second period and third period). Each sequence receives a same dose of HR17031 at every period.
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06086912
- Sponsor's protocol ID
- HR17031-106
- Status last verified
- Jan 2024
- First submitted
- 12 Oct 2023
- Last updated
- 1 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open, Three-period, Three-sequence Crossover Clinical Study to Compare the Bioavailability and Safety of a Single Subcutaneous Injection of HR17031 in Healthy Subjects at Different Sites
- ClinicalTrials.gov ID
- NCT06086912
- Acronym / sponsor ID
- HR17031-106
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 17 Oct 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 purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a single-center, randomized, open-label, three-period, and three-sequence crossover design trial, consisting of three sequences (sequence 1, sequence 2 and sequence 3) and three periods (first period, second period and third period). Each sequence receives a same dose of HR17031 at every period.
| Arm | Type | Receives |
|---|---|---|
| sequence 1 | Experimental | Drug: HR17031 |
| sequence 2 | Experimental | Drug: HR17031 |
| sequence 3 | Experimental | Drug: HR17031 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.
- Both men and women are eligible, aged 18 to 55 years old (inclusive, as determined at the time of signing informed consent form).
- Body mass index (BMI) is between 18 and 27 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- Fasting blood glucose level < 6.1 mmol/L during screening period.
Key exclusion criteria (29 listed)
- -
- 1. The following laboratory or auxiliary examination abnormalities are present during the screening period:
- Any abnormal laboratory examination with clinical significance. For laboratory examinations with clinical significance, if there is a clear and reasonable reason, retesting can be performed within one week and the retest results used to determine whether the subject meets the criteria;
- Abnormalities on 12-lead electrocardiogram (ECG) with clinical significance;
- Positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C antibody (anti-HCV) (or diagnosed as active hepatitis), or positive for syphilis antibody;
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 |
|---|---|---|
| HR17031Receive a single dose of HR17031 at every period (First period：abdomen. Second period. upper arm. Third period: thigh). | Drug | sequence 1 |
| HR17031Receive a single dose of HR17031 at every period (First period：upper arm. Second period: thigh. Third period: abdomen). | Drug | sequence 2 |
| HR17031Receive a single dose of HR17031 at every period (First period：thigh. Second period: abdomen. Third period: upper arm). | Drug | sequence 3 |
Primary outcome
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-t)
Time frame: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-∞)
Time frame: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Maximum Concentration (Cmax)
Time frame: Start of treatment up to Day 26
7 secondary outcomes
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Time to maximum concentration (Tmax)
Time frame: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent terminal half-life (t1/2)
Time frame: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Clearance (CL/F)
Time frame: Start of treatment up to Day 26
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent volume of distribution (Vz/F)
Time frame: Start of treatment up to Day 26
Safety indicators: Adverse events (AE, including Injection site reactions, Hypoglycemia events, etc.), serious adverse events (SAE).
Time frame: Screening period up to Day 26
Immunogenicity indicators: anti-Noiiglutide antibodies
Time frame: Start of treatment up to Day 26
Immunogenicity indicators: anti-INS068 antibodies
Time frame: Start of treatment up to Day 26
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 1 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 HR17031 in people with Type 2 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 29 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 1 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?
After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-t) (time frame: Start of treatment up to Day 26). The study lists 3 primary outcomes in all. 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 1 Feb 2024.