> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-trials-of-ibi3035-in-healthy-subjects-85bfce83-646a-44c9-85d4-1d74df768c00 > Record changed: 2026-10-13 # Clinical Trials of IBI3035 in Healthy Subjects NCT07591519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Lead sponsor Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Start date 2026-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Short title** Clinical Trials of IBI3035 in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Dates **Completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **First posted** 2026-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Primary completion date** 2027-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Start date** 2026-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Lead sponsor** Innovent Biologics (Suzhou) Co. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Identifiers **Registry ID** NCT07591519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **ClinicalTrials.gov ID** NCT07591519 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Outcomes ### Primary outcomes 1. The area under the blood drug concentration-time curve from 0 to 168 hours Timeframe: From 0 to 168 hours after administration 2. Area Under Curve Glucose Infusion Rate (AUCGIR) 0-168h Timeframe: From 0 to 168 hours after administration ### Secondary outcomes 1. Area Under Curve (AUC0-84h) Timeframe: From 0 to 84 hours after administration 2. Tmax Timeframe: From 0 to 168 hours after administration 3. Glucose Infusion Rate (GIR) max Timeframe: From 0 to 168 hours after administration 4. Area Under Curve Glucose Infusion Rate (AUCGIR) 24-48h Timeframe: From 24 to 48 hours after administration 5. Adverse events (AE) Timeframe: through study completion, an average of 16 weeks 6. The generation of Anti-drug antibodies (ADA) and Neutrolizing antibodies (NAb if required) Timeframe: through study completion, an average of 16 weeks 7. Area Under Curve (AUC) 84-168h Timeframe: From 84 to 168 hours after administration 8. Cmax Timeframe: From 0 to 168 hours after administration 9. T1/2 Timeframe: From 0 to 168 hours after administration 10. tGIRmax Timeframe: From 0 to 168 hours after administration 11. AUCGIR 144-168h Timeframe: From 144 to 168 hours after administration 12. vital signs (Body temperature) Timeframe: through study completion, an average of 16 weeks 13. laboratory tests (fasting plasma glucose (GLU)) Timeframe: through study completion, an average of 16 weeks 14. 12-lead Electrocardiogram (RR interval, PR interval, heart rate (HR), QRS interval, QT interval, QTcF (QTcF = QT/RR^0.33)) Timeframe: through study completion, an average of 16 weeks 15. vital signs (pulse) Timeframe: through study completion, an average of 16 weeks 16. vital signs (respiratory rate) Timeframe: through study completion, an average of 16 weeks 17. vital signs (blood pressure: systolic, diastolic) Timeframe: through study completion, an average of 16 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria The following inclusion criteria must be met: 1. 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; 2. Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg; 3. 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 \[confirmed by the insulin release test (IRT)\]; 4. Glycated hemoglobin ≤ 6.0% at screening; 5. 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; 6. 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. ### Exclusion criteria Subjects who meet any of the following exclusion criteria cannot be included in this study: 1. Known or suspected to be allergic to the investigational drug in this study; 2. Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.); 3. 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; 4. Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening; 5. Have an increased risk of thrombosis at screening, including personal or family history of deep vein thrombosis; 6. 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; 7. Have had a severe infection, trauma, or surgery within 4 weeks before screening; 8. 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; 9. 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; 10. 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; 11. 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; 12. 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; 13. Have positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies; 14. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Sites - Bishan Hospital of ChongqingChongqing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## References ### Other registry identifiers - MR-50-26-033399 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07591519) ## Related records ### Drugs (1) - [Insulin icodec](https://trialight.com/data/asset/insulin-icodec-fa77ad93-ab76-47ee-8df1-57e5650af79a.md) ### Lead sponsors (1) - [Innovent Biologics (Suzhou) Co. Ltd.](https://trialight.com/data/company/innovent-biologics-suzhou-co-ltd-cd395d6d-f2bc-41a8-9a5c-6d6d1871bceb.md) ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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