Healthy PersonPhase 1NCT07591519
Clinical Trials of IBI3035 in Healthy Subjects
A Phase 1 study testing IBI3035 and Insulin icodec Injection in people with Healthy Person, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Person
- What is being tested?
- IBI3035 and Insulin icodec Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 31 Aug 2027
- Phase
- Phase 1
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The following inclusion criteria must be met:
- Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality;
- Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg;
- Normal glucose tolerance at screening [3.9 mmol/L < fasting blood glucose < 6.1 mmol/L, and 2-hour post-glucose load blood glucose < 7.8 mmol/L in the oral glucose tolerance test (OGTT)]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator [confirmed by the insulin release test (IRT)];
- Glycated hemoglobin ≤ 6.0% at screening;
- Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm;
- Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form.
Who cannot join
- Subjects who meet any of the following exclusion criteria cannot be included in this study:
- Known or suspected to be allergic to the investigational drug in this study;
- Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.);
- Have a history of clinical significance as determined by the investigator at screening or before randomization, including diseases of the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, or any other disease that can significantly alter the absorption, metabolism, or elimination of drugs;
- Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening;
- Have an increased risk of thrombosis at screening, including personal or family history of deep vein thrombosis;
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- Have abnormal indicators with clinical significance at screening or before randomization: vital signs, physical examination, laboratory tests, chest X-ray, and 12-lead ECG as determined by the investigator;
- Have had a severe infection, trauma, or surgery within 4 weeks before screening;
- Have smoked more than 5 cigarettes per day within 3 months before screening, or have smoked within 48 hours before using the investigational drug or cannot stop using any tobacco products during the trial;
- Have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or health supplements (except for regular vitamin supplements) within 2 weeks before screening;
- Have donated blood ≥ 400 ml or had any component blood donation within 3 months before screening, or have lost a total of ≥ 400 ml of blood for any reason, or have a history of blood transfusion or use of blood products;
- Have consumed more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 ml of beer, or 45 ml of spirits, or 150 ml of wine, and cannot abstain from alcohol within 48 hours before using the investigational drug;
- Have consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 ml) daily within 3 months before screening;
- Have positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies;
- Have a history of drug abuse or drug use within 3 months before screening, or have positive results for alcohol tests or urine drug screening at screening. 15. Participants who have participated in other clinical trials and used investigational drugs or medical devices within the 3 months prior to screening;
- 16. Participants with a weight change greater than 5% within the 3 months prior to screening [(maximum weight within the 3 months prior to screening - minimum weight within the 3 months prior to screening) / minimum weight within the 3 months prior to screening × 100%, as self-reported by the participant]; 17. Participants with any food allergies or special dietary requirements that prevent them from adhering to a uniform diet (such as intolerance to standard meal foods, lactose intolerance, etc.); 18. Participants who have experienced acute diseases during the screening period; 19. Participants with a history of fainting at the sight of needles or blood, who cannot tolerate venipuncture blood collection, or who have difficulty with blood collection; 20. Participants for whom the investigator deems there to be any circumstances that make them unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bishan Hospital of Chongqing
Chongqing, Chongqing Municipality, 402760
Chengyong Tang, 18983286980, 17235387@qq.com
About this study
Official title: Evaluation of the Pharmacokinetics and Pharmacodynamics of IBI3035 and Awiqli? (Ecoporin Insulin Injection) in a Randomized, Open-label, Single-dose, Two-formulation, Crossover Design in Healthy Male Subjects in China: A Phase I Clinical Trial.
This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects
- Conditions
- Healthy Person
- Being tested
- IBI3035, Insulin icodec Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3035Biological
IBI3035 administered subcutaneously(SC)
Insulin icodec InjectionBiological
Insulin icodec Injection administered subcutaneously(SC)
| Study group | Role | What they receive |
|---|---|---|
| Insulin icodec Injection | Active comparator | The first cycle is Awiqli® 1 U/kg, and the second cycle is IBI3035 1 U/kg Receives: Biological: IBI3035; Biological: Insulin icodec Injection |
| IBI3035 | Experimental | The first cycle is IBI3035 1 U/kg, and the second cycle is Awiqli® 1 U/kg Receives: Biological: IBI3035; Biological: Insulin icodec Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the blood drug concentration-time curve from 0 to 168 hours
Measured: From 0 to 168 hours after administration
Area Under Curve Glucose Infusion Rate (AUCGIR) 0-168h
Measured: From 0 to 168 hours after administration
Secondary outcomes (17)
Area Under Curve (AUC0-84h)
Measured: From 0 to 84 hours after administration
Tmax
Measured: From 0 to 168 hours after administration
Glucose Infusion Rate (GIR) max
Measured: From 0 to 168 hours after administration
Area Under Curve Glucose Infusion Rate (AUCGIR) 24-48h
Measured: From 24 to 48 hours after administration
Adverse events (AE)
Measured: through study completion, an average of 16 weeks
The generation of Anti-drug antibodies (ADA) and Neutrolizing antibodies (NAb if required)
Measured: through study completion, an average of 16 weeks
Area Under Curve (AUC) 84-168h
Measured: From 84 to 168 hours after administration
Cmax
Measured: From 0 to 168 hours after administration
T1/2
Measured: From 0 to 168 hours after administration
tGIRmax
Measured: From 0 to 168 hours after administration
AUCGIR 144-168h
Measured: From 144 to 168 hours after administration
vital signs (Body temperature)
Measured: through study completion, an average of 16 weeks
laboratory tests (fasting plasma glucose (GLU))
Measured: through study completion, an average of 16 weeks
12-lead Electrocardiogram (RR interval, PR interval, heart rate (HR), QRS interval, QT interval, QTcF (QTcF = QT/RR^0.33))
Measured: through study completion, an average of 16 weeks
vital signs (pulse)
Measured: through study completion, an average of 16 weeks
vital signs (respiratory rate)
Measured: through study completion, an average of 16 weeks
vital signs (blood pressure: systolic, diastolic)
Measured: through study completion, an average of 16 weeks
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 start8 May 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591519
- Sponsor's protocol ID
- CIBI3035A101CN
- Other IDs
- MR-50-26-033399
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No