Clinical trial NCT04237129: PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Official title: A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes
Insulin
Diabetes Mellitus
Basal
Bolus
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: AUCins.0-12h
timeFrame: 0 -12 hours
measure: Cins.max
timeFrame: 0 -12 hours
measure: AUCGIR.0-12h
timeFrame: 0 - 12 hours
measure: GIRmax
timeFrame: 0 - 12 hours
Secondary outcomes:
measure: AUCins.0-2h
timeFrame: 0 - 2 hours
measure: AUCins.0-∞
timeFrame: 0 - 12 hours
measure: tins.max
timeFrame: Up to Day 68
measure: t50%-ins(early)
timeFrame: Up to Day 68
measure: t50%-ins(late)
timeFrame: Up to Day 68
measure: t½
timeFrame: Up to Day 68
measure: λz
timeFrame: Up to Day 68
measure: AUCGIR.0-2h
timeFrame: 0 - 2 hours
measure: tGIR.max
timeFrame: Up to Day 68
measure: tGIR.50%-early
timeFrame: Up to Day 68
measure: tGIR.50%-late
timeFrame: Up to Day 68
measure: PD endpoint
timeFrame: Up to Day 68
measure: Safety and local tolerability
timeFrame: Up to Day 68
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co. KG
state: Rhineland-Palatinate
Study officials:
affiliation: Gan & Lee Pharmaceuticals USA Corporation
name: Matthew E Barton, PhD
role: STUDY_DIRECTOR
References: