Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how well two different forms of insulin work in the body for healthy Chinese males. Specifically, it compares insulin capsules to insulin injections to see which one is more effective and how they are absorbed. The goal is to learn more about these insulin options, which could help improve diabetes treatment in the future.

To participate, you need to be a healthy male between the ages of 20 and 35, with a normal body weight and good blood sugar levels. You also need to be free from major health issues and not be taking certain medications or supplements that could affect the results. If you join the study, you will undergo health checks and will be closely monitored as you take either the insulin capsules or injections. This trial is not yet recruiting, so there’s no need to apply just yet, but if you meet the criteria, it could be an opportunity to contribute to important diabetes research.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy Chinese male subjects aged 20-35 (inclusive);
• • 2. Body mass index (BMI) between 19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
• • 3. Normal oral glucose tolerance Test (fasting plasma glucose \[FPG\]\< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose \[2hPG\]\< 7.8 mmol/L), and HbA1C\<6.0%
• • 4. Normal insulin releasing test (judged by investigator);
• • 5. Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
• • 6. Signed informed consent and volunteers' consent to all restrictions imposed during the study.
• Exclusion Criteria:
• • 1. Known allergic or suspected hypersensitivity to investigational product (IP) or related product
• • 2. Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
• • 3. History of heavy smoking, alcohol abuse, and drug abuse;
• • 4. Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial;
• • 5. Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
• • 6. Use of any medication that may affect glucose lowering effect (such as oral contraceptives, corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroid hormone, etc.) within 28 days prior to screening;
• • 7. Taking any medications, vitamin products, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
• • 8. Participation in any clinical trial less than 3 months prior to screening or planning to participate in other trials after ICF signed.
• • 9. Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; history of blood transfusion or component blood transfusion; failure to guarantee not to donate whole blood / component blood (such as plasma, platelets) during the trial or within 30 days after the end of the trial;
• • 10. Undergo surgery prior to IP administration within 1month or plan to undergo surgery during the trial;
• • 11. Occurrence of acute disease during screening;
• • 12. Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TP-Ab;
• • 13. History of needle phobia and blood phobia;
• • 14. Any conditions that make volunteer participation ineligible judged by investigating physician.