A Study Evaluating the Bioavailability of Oral Insulin (N11005)

NCT04975022 | Completed Phase 1

• 1 other identifier: 12013-P-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

Conditions

PK, PD, and Safety

Outcome Measures

Primary Outcomes (4)

• Cmax

  the peak concentration

  Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；

• AUC 0-8 h

  the AUC for insulin from time zero to 8 hours

  Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；

• AUCGIR,0-8 h

  Pre-dose, 0-8 hours

• GIRmax

  Pre-dose, 0-8 hours

Secondary Outcomes (8)

• Tmax

  Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes；

• AUC 0-2 h

  Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes

• the elimination half-life (t1/2) of serum insulin

  Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；

• the AUC for insulin from time zero to 4 h

  Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240 minutes

• the AUC for insulin from time zero to infinite time

  Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；

Study Arms (2)

T group

EXPERIMENTAL

Drug: N11005

R group

ACTIVE COMPARATOR

Drug: Novolin R

Interventions

N11005 DRUG

oral insulin N11005, 300IU, p.o.

T group

Novolin R DRUG

reference preparation Novolin R, 0.1 IU/Kg, i.h.

R group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; No abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) BMI (body mass index): between 19-24 Kg/m2, including 19 and 24 Kg/m2; 4) Normal glucose tolerance (fasting plasma glucose \[FPG\] \<6.1 mmol/L, and oral glucose tolerance test \[OGTT\] 2-hour postprandial blood glucose \<7.8 mmol/L); 5) No family history of diabetes, obesity, etc.; 6) Insulin secretion function is normal (confirmed by insulin release test (IRT) judged by the investigator); 7) There is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug; 8) Be able to communicate well with researchers and complete research in accordance with research regulations.

You may not qualify if:

• ). Those who have serious systemic diseases, infectious diseases or mental disorders; 2). The results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis test are positive; 3). Those who have used any prescription drugs, Chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). Those who donated more than 400 mL of blood within 3 months before screening; 5). Severe smokers (25 or more cigarettes per day); 6). Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who have a positive alcohol breath test result; 7). Those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). Those who are known or suspected to be allergic to insulin and/or its excipients; 9). Those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). Those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). Those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). Those who are using gastric mucosal protective agents during screening; 13). Those who are deemed unsuitable to participate in this trial after the researcher's evaluation;

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, China

Location

Related Publications (1)

• Pan Q, Wang X, Li W, Chen X, Zhuang Y, Zhou Q, Huang Y, Zhou Y, Lan L, Wang Z, Wang W, Hong J, Hao WH, Yang YT, Guo L. Pharmacokinetics, pharmacodynamics, and safety of prandial oral insulin (N11005) in healthy subjects. Front Endocrinol (Lausanne). 2023 Jul 26;14:1172327. doi: 10.3389/fendo.2023.1172327. eCollection 2023.

  PMID: 37564986 DERIVED

MeSH Terms

Interventions

Insulin

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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 23, 2021
• Study Start: December 10, 2019
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

CN (1)