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

NCT06519604 | Active Not Recruiting Phase 1

• 1 other identifier: ORA-H-CN-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (4)

• GIRmax

  PD endpoint: The maximum glucose infusion rate

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• TGIRmax

  PD endpoint: The time to maximum observed glucose infusion rate

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• AUCGIR.0-11h

  PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• AUCGIR0-∞

  PD endpoint: The area under the glucose infusion rate curve from 0 to infinity

  0 -11 hours (hyperinsulinemic euglycemic clamp)

Secondary Outcomes (4)

• Cmax

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• Tmax

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• AUCIns0-11h

  0 -11 hours (hyperinsulinemic euglycemic clamp)

• AUCIns0-∞

  0 -11 hours (hyperinsulinemic euglycemic clamp)

Other Outcomes (3)

• Relative biopotency

  0-11 hours (hyperinsulinemic euglycemic clamp)

• Relative bioavailability

  0-11 hours (hyperinsulinemic euglycemic clamp)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Up to Day 14

Study Arms (3)

Human insulin enteric coated capsules in dose 16mg

EXPERIMENTAL

Single oral administration of human insulin enteric coated capsules in dose 16mg.

Drug: Human insulin enteric coated capsules in dose 16mg

Human insulin enteric coated capsules in dose 8mg

EXPERIMENTAL

Single oral administration of human insulin enteric coated capsules in dose 8mg

Drug: Human insulin enteric coated capsules in dose 8mg

Human Insulin Injection in dose 5IU

ACTIVE COMPARATOR

Single subcutaneous administration of Human Insulin Injection in dose 5IU

Drug: Human Insulin Injection in dose 5IU

Interventions

Human insulin enteric coated capsules in dose 16mg DRUG

Single oral administration of human insulin enteric coated capsules in dose 16mg

Human insulin enteric coated capsules in dose 16mg

Human insulin enteric coated capsules in dose 8mg DRUG

Single oral administration of human insulin enteric coated capsules in dose 16mg

Human insulin enteric coated capsules in dose 8mg

Human Insulin Injection in dose 5IU DRUG

Single subcutaneous administration of Human Insulin Injection in dose 5IU

Human Insulin Injection in dose 5IU

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

uijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was open for subjects, sponsor and investigators except for analytical laboratory.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PHD, MD

Model Details: two-way crossover

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 25, 2024
• Study Start: July 17, 2024
• Primary Completion: September 13, 2024
• Study Completion: October 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)