Healthy men to test two insulin shots in Early-Stage study
NCT ID NCT07591519
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This early-stage trial will compare two insulin formulations—IBI3035 and insulin icodec (Awiqli)—in 144 healthy Chinese men aged 18 to 45. Researchers will measure how the body absorbs and processes each insulin and how they affect blood sugar levels. The goal is to see if the two formulations are similar enough to be considered interchangeable, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI3035 and insulin icodec (Awiqli)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy person are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Bishan Hospital of Chongqing
RECRUITINGChongqing, Chongqing Municipality, 402760, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.