Clinical trial NCT06519604: Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males
Official title: An Open, Randomized, Single Dose, Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Diabete Mellitus
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU

Detailed description: An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp.

Eligibility criteria: Inclusion Criteria:

* Healthy Chinese male subjects aged 20-35 (inclusive);
* Body mass index (BMI) between19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
* 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%
* Normal insulin releasing test (judged by investigator);
* 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.
* Signed informed consent and volunteers' consent to all restrictions imposed during the study.

Exclusion Criteria:

* Known allergic or suspected hypersensitivity to investigational product (IP) or related product
* 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;
* History of heavy smoking, alcohol abuse, and drug abuse;
* 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 ;
* 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;
* 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;
* Taking any medications, vitamin product, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
* Participation in any clinical trial less than 3 months prior to screening or plan to participate in other trials after ICF signed.
* Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; blood transfusion or component blood transfusion within 3 months prior to screening; 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;
* Undergo surgery prior to IP administration within 1 month or plan to undergo surgery during the trial;
* Occurrence of acute disease during screening;
* Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TPAb;
* history of needle phobia and blood phobia;
* Any conditions that make volunteer participation is ineligible judged by investigating physician.

Primary outcomes:
measure: GIRmax
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: TGIRmax
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: AUCGIR.0-11h
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: AUCGIR0-∞
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
Secondary outcomes:
measure: Cmax
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: Tmax
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: AUCIns0-11h
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
measure: AUCIns0-∞
timeFrame: 0 -11 hours (hyperinsulinemic euglycemic clamp)
Other outcomes:
measure: Relative biopotency
timeFrame: 0-11 hours (hyperinsulinemic euglycemic clamp)
measure: Relative bioavailability
timeFrame: 0-11 hours (hyperinsulinemic euglycemic clamp)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to Day 14
Locations:
city: Shanghai
country: China
facility: uijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: