Healthy SubjectsPhase 1NCT07588906
To Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability Between SHR-3167 Injection and Glargine Insulin in Healthy Subjects
A Phase 1 study testing SHR-3167 injection；glargine insulin in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the pharmacodynamic profile of a single subcutaneous dose of SHR-3167 injection versus insulin glargine U100 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SHR-3167 injection；glargine insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2024to 23 Jul 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily participate in the trial and sign the informed consent form; as judged by the researcher, the subjects are willing and able to adhere to all trial requirements and restrictions.
- Healthy males, aged 18-55 years (inclusive).
- Body mass index (BMI) within the range of 19.0-24.0 kg/m2 (inclusive); weight ≥50 kg.
- Venous fasting blood glucose, oral glucose tolerance test (OGTT) 0 h venous glucose <6.1 mmol/L and >3.9 mmol/L; OGTT 2 h blood glucose <7.8 mmol/L; insulin release test (IRT) results are normal, or abnormal but judged by the researcher to have no clinical significance; glycated hemoglobin ≤6.0%.
- No clinically significant history of past and/or present abnormalities in the heart, liver, kidneys, digestive system, nervous system, respiratory system, mental health, and metabolic conditions, as judged by the researcher; vital signs, physical examination, electrocardiogram, laboratory tests, and chest X-rays show no abnormalities or abnormalities deemed clinically insignificant (as determined by a clinical physician).
- Agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and to refrain from donating sperm during this period.
- The researcher judges that the skin at the intended injection site of the investigational drug on the abdominal wall is normal, without fat hypertrophy, skin depressions, skin indurations, scars, inflammation, edema, ulcers, infections, bleeding, or any other condition that may affect the administration of the investigational drug to the subjects.
- Capable of good communication with the researcher and able to comply with the trial requirements to complete the study
Who cannot join
- History of diabetes or a first-degree relative with a history of diabetes.
- History of hypokalemia, orthostatic hypotension, syncope, blackout, or severe hypoglycemic episodes.
- Conditions judged by the investigator to potentially affect drug absorption, distribution, metabolism, excretion, safety assessment, or compliance, or if the investigator believes that participation in the trial poses a safety risk to the subject.
- History of poorly controlled acute or chronic respiratory diseases in the 6 months prior to screening, including but not limited to chronic obstructive pulmonary disease (COPD), severe asthma, severe pneumonia, severe or critical COVID-19, active pulmonary tuberculosis.
- Underwent any major surgery in the 6 months prior to screening or planned elective surgery during or within 1 month after dosing. Major surgery is defined as surgery that results in significant tissue trauma to organs within the skull, chest, abdomen, pelvis, or limbs and requires long-term recovery (e.g., organ transplantation, cardiac surgery, or joint replacement).
- Donated blood (including blood components) or experienced blood loss exceeding 400mL in the 3 months prior to screening, or received a blood transfusion or blood products.
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- History of severe hypersensitivity reactions or known allergy to the investigational drug, its excipients, insulin, or insulin analogs.
- History of drug abuse in the 12 months prior to screening or a positive result on a prohibited substance urine test.
- Participated in any approved or unapproved clinical trial of investigational drugs/devices in the 90 days prior to screening, or planned to participate in another clinical trial during or within 1 month after the trial period.
- Positive test results for human immunodeficiency virus antigen/antibody (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or Treponema pallidum antibody (TP).
- Persons who have had an acute illness during the screening period.
- Persons who have regularly consumed alcohol in the six months prior to screening (consuming more than 14 units of alcohol per week, with 1 unit approximately equal to 360mL of beer, 45mL of 40% alcohol spirit, or 150mL of wine); or those who have had a positive alcohol breath test at baseline or are unwilling to abstain from alcohol during the trial.
- Persons who have smoked an average of more than 5 cigarettes per day in the three months prior to screening, or are unwilling to quit smoking before the completion of all glucose clamp tests.
- Persons who have used any prescription drugs, traditional Chinese medicine, herbal medicine, or over-the-counter drugs, supplements, or have received any vaccinations in the four weeks prior to dosing.
- Persons who have taken any medications affecting insulin lowering in the 28 days prior to screening (e.g., corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroxine, etc.).
- Persons who have consumed excessive tea, coffee, or caffeine-containing beverages (≥8 cups, with 1 cup = 250mL) daily in the two weeks prior to dosing, or do not agree to abstain from consuming grapefruit juice or any foods and beverages containing alcohol and xanthine (including chocolate, tea, coffee, cola, etc.) for 48 hours before dosing and until the completion of all glucose clamp tests.
- Persons who have made significant changes in diet or exercise habits in the three months prior to screening, such as weight loss or intense exercise.
- Persons who are unwilling or unable to follow the lifestyle guidance described in the trial protocol, have special dietary requirements, or cannot adhere to a standardized diet.
- Persons who cannot tolerate venipuncture, have difficulty with blood sampling, have a history of fainting or fainting at the sight of needles, or cannot establish a venous route in both upper limbs.
- Persons who are directly involved in this trial as staff of the research center or sponsor, or their immediate relatives (spouse, parents/legal guardians, siblings, or children).
- Other conditions that the researcher deems unsuitable for the participant to take part in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Bishan Hospital of Chongqing
Chongqing, Chongqing Municipality, 400000
About this study
Official title: A Phase I Clinical Trial of the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Injection of SHR-3167 Injection and Glargine Insulin in Healthy Subjects
The purpose of this study is to compare the pharmacodynamic profile of a single subcutaneous dose of SHR-3167 injection versus insulin glargine U100 in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- SHR-3167 injection；glargine insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3167 injection；glargine insulinDrug
Drug: SHR-3167 injection Participants will receive a single subcutaneous (s.c.) injections of SHR-3167 injection Drug: glargine insulin Participants will receive a single subcutaneous (s.c.) injections of glargine insulin
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine followed by SHR-3167 injection | Experimental | Participants will receive a single injection of glargine in the Glargine period and then washout. After that, participants will receive a single injection of SHR-3167 in the SHR-3167 period. Receives: Drug: SHR-3167 injection；glargine insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose infusion rate (GIR) - area under the curve (AUC)
Measured: Glargine period: 0-24hour ; SHR-3167 period: 0-226hour
Secondary outcomes (10)
area under the curve (AUC0-t, AUC0-∞)
Measured: 0-1680 hour
maximum concentration (Cmax)
Measured: 0-1680 hour
time to reach maximum concentration (Tmax)
Measured: 0-1680 hour
half-life (t1/2)
Measured: 0-1680 hour
apparent clearance (CL/F)
Measured: 0-1680 hour
apparent volume of distribution (Vz/F).
Measured: 0-1680 hour
Change in fasting blood glucose from baseline.
Measured: 0-1680 hour
Hypoglycemic events
Measured: 0-1680 hour
adverse events (AE)
Measured: 0-1680 hour
Change in fasting C-peptide from baseline
Measured: 0-1680 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start26 Feb 2024
- Primary completion12 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Sequential
- 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
- NCT07588906
- Sponsor's protocol ID
- SHR-3167-102
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Injection of SHR-3167 Injection and Glargine Insulin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07588906
- Acronym / sponsor ID
- SHR-3167-102
- Conditions
- Healthy Subjects
- 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
- 26 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 15 May 2026 (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 compare the pharmacodynamic profile of a single subcutaneous dose of SHR-3167 injection versus insulin glargine U100 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin glargine followed by SHR-3167 injection | Experimental | Drug: SHR-3167 injection；glargine insulinParticipants will receive a single injection of glargine in the Glargine period and then washout. After that, participants will receive a single injection of SHR-3167 in the SHR-3167 period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Voluntarily participate in the trial and sign the informed consent form; as judged by the researcher, the subjects are willing and able to adhere to all trial requirements and restrictions.
- Healthy males, aged 18-55 years (inclusive).
- Body mass index (BMI) within the range of 19.0-24.0 kg/m2 (inclusive); weight ≥50 kg.
- Venous fasting blood glucose, oral glucose tolerance test (OGTT) 0 h venous glucose <6.1 mmol/L and >3.9 mmol/L; OGTT 2 h blood glucose <7.8 mmol/L; insulin release test (IRT) results are normal, or abnormal but judged by the researcher to have no clinical significance; glycated hemoglobin ≤6.0%.
- No clinically significant history of past and/or present abnormalities in the heart, liver, kidneys, digestive system, nervous system, respiratory system, mental health, and metabolic conditions, as judged by the researcher; vital signs, physical examination, electrocardiogram, laboratory tests, and chest X-rays show no abnormalities or abnormalities deemed clinically insignificant (as determined by a clinical physician).
Key exclusion criteria (21 listed)
- History of diabetes or a first-degree relative with a history of diabetes.
- History of hypokalemia, orthostatic hypotension, syncope, blackout, or severe hypoglycemic episodes.
- Conditions judged by the investigator to potentially affect drug absorption, distribution, metabolism, excretion, safety assessment, or compliance, or if the investigator believes that participation in the trial poses a safety risk to the subject.
- History of poorly controlled acute or chronic respiratory diseases in the 6 months prior to screening, including but not limited to chronic obstructive pulmonary disease (COPD), severe asthma, severe pneumonia, severe or critical COVID-19, active pulmonary tuberculosis.
- Underwent any major surgery in the 6 months prior to screening or planned elective surgery during or within 1 month after dosing. Major surgery is defined as surgery that results in significant tissue trauma to organs within the skull, chest, abdomen, pelvis, or limbs and requires long-term recovery (e.g., organ transplantation, cardiac surgery, or joint replacement).
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 |
|---|---|---|
| SHR-3167 injection；glargine insulinDrug: SHR-3167 injection Participants will receive a single subcutaneous (s.c.) injections of SHR-3167 injection Drug: glargine insulin Participants will receive a single subcutaneous (s.c.) injections of glargine insulin | Drug | insulin glargine followed by SHR-3167 injection |
Primary outcome
Glucose infusion rate (GIR) - area under the curve (AUC)
Time frame: Glargine period: 0-24hour ; SHR-3167 period: 0-226hour
10 secondary outcomes
area under the curve (AUC0-t, AUC0-∞)
Time frame: 0-1680 hour
maximum concentration (Cmax)
Time frame: 0-1680 hour
time to reach maximum concentration (Tmax)
Time frame: 0-1680 hour
half-life (t1/2)
Time frame: 0-1680 hour
apparent clearance (CL/F)
Time frame: 0-1680 hour
apparent volume of distribution (Vz/F).
Time frame: 0-1680 hour
Change in fasting blood glucose from baseline.
Time frame: 0-1680 hour
Hypoglycemic events
Time frame: 0-1680 hour
adverse events (AE)
Time frame: 0-1680 hour
Change in fasting C-peptide from baseline
Time frame: 0-1680 hour
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 15 May 2026.
- 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 SHR-3167 injection；glargine insulin in people with Healthy Subjects, 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 8 inclusion and 21 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 15 May 2026. 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?
Glucose infusion rate (GIR) - area under the curve (AUC) (time frame: Glargine period: 0-24hour ; SHR-3167 period: 0-226hour). 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 15 May 2026.