PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Gan and Lee Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Gan & Lee Insulin Aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT04237129

GL-ASP-1008

Details and patient eligibility

About

Primary objective:

To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects

Secondary objectives:

To compare the PK and PD parameters of the three insulin aspart preparations

To evaluate the single dose safety and local tolerability of the three insulin aspart preparations

Enrollment: 36 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
2. Healthy male subjects
3. Age between 18 and 64 years, both inclusive
4. Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
5. Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening
6. Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator

Exclusion criteria

1. Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
2. Previous participation in this trial. Participation is defined as randomized
3. Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
5. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
6. Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
7. A positive result in the alcohol and/or urine drug screen at the screening visit
8. Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
9. Blood donation or blood loss of m ore than 500 mL within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Gan & Lee Insulin Aspart

Experimental group

Description:

100 units/mL, 3 ml prefilled pen

Treatment:

Drug: Gan & Lee Insulin Aspart

NovoRapid® Insulin Aspart

Active Comparator group

Description:

Product approved and marketed in the EU FlexPen100 units/mL prefilled pen

Treatment:

Drug: Gan & Lee Insulin Aspart

NovoLog® Insulin Aspart

Active Comparator group

Description:

Product approved and marketed in the US FlexPen100 units/mL prefilled pen

Treatment:

Drug: Gan & Lee Insulin Aspart