A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers

NCT06481189 | Completed Phase 1

• 1 other identifier: CAN-HVL-I
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.

Conditions

Healthy Volunteers

Keywords

canakinumab; humanized monoclonal antibodies; safety; pharmacokinetics; equivalence; biosimilar; pharmacodynamics; interleukine-1β

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

  Analysis of equivalence of area under concentration-time curve from time 0 (predose) extrapolated to infinity (AUC(0-∞) of GNR-086 and Ilaris®

  Day 120

• Pharmacokinetics: Peak Plasma Concentration (Cmax)

  Analysis of equivalence of Cmax of GNR-086 and Ilaris®

  Day 120

Secondary Outcomes (4)

• Pharmacodynamics: interleukin-1β (IL-1β)

  Day 120

• Pharmacodynamics: Area Under IL-1β Curve (AUC)

  Day 120

• Proportion of volunteers with adverse events (AE)

  Day 120

• Immunogenicity

  Day 120

Study Arms (2)

GNR-086 (JSC "GENERIUM", Russia)

EXPERIMENTAL

canakinumab biosimilar

Biological: GNR-086

Ilaris® (Novartis Pharma Stein AG, Switzerland)

ACTIVE COMPARATOR

canakinumab

Biological: Ilaris®

Interventions

GNR-086 BIOLOGICAL

The test drug GNR-086 was administered as a subcutaneous injection at a single dose of 150 mg.

Also known as: canakinumab

GNR-086 (JSC "GENERIUM", Russia)

Ilaris® BIOLOGICAL

The reference drug Ilaris® was administered as a subcutaneous injection at a single dose of 150 mg.

Also known as: canakinumab

Ilaris® (Novartis Pharma Stein AG, Switzerland)

Eligibility Criteria

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

You may qualify if:

• Written informed consent to participate in the study, obtained from the volunteer before the start of any procedures related to the study;
• Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form;
• Verified diagnosis "healthy" (the diagnosis "healthy" is established on the basis of a detailed medical history, in the absence of deviations from normal values during a clinical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory data studies, results of electrocardiography and fluorography);
• Body weight from 50 to 85 kg, body mass index from 18.5 to 28 kg/m2, inclusive.
• Agreement to adhere to adequate methods of contraception during the entire period of participation in the study or for 3 months after administration of the study or reference drug in case of early termination of participation in the study.

You may not qualify if:

• Severe chronic diseases, history of seizures;
• Acute infectious diseases less than 4 weeks before administration of the study or reference drug;
• Any history of chronic or recurrent infectious diseases;
• History of tuberculosis;
• Vaccination with any vaccine within 3 months before the administration of the study or reference drug or planned for the period of the volunteer's participation in the study;
• Compounded allergy history; history of hypersensitivity to the active substance or other components of the study or reference drug;
• Pregnancy or breastfeeding period;
• Special lifestyle (work at night, extreme physical activity);
• Deviations of vital signs: systolic pressure less than 100 mm Hg. Art. or more than 130 mm Hg. Art.; diastolic pressure less than 60 mm Hg. Art. or more than 90 mm Hg. Art.; heart rate less than 60 beats/min or more than 90 beats/min;
• Dehydration due to diarrhea, vomiting, or other cause within 24 hours prior to administration of the study or reference drug;
• Taking prescription medications within 28 days or 5 half-lives (whichever is longer) or taking over-the-counter medications/dietary supplements within 14 days prior to study or reference drug administration (occasional use of paracetamol at any time prior to study drug administration is acceptable) or reference drug);
• Blood donation or blood loss (450 ml of blood or more) less than 3 months before the administration of the study or reference drug and/or blood donation in any quantity planned for the period of the volunteer's participation in the study;
• Participation in clinical trials of medicinal products (less than 3 months or 5 half-lives from the study drug, whichever is longer) before administration of the investigational or reference drug of this study;
• Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol or 325 ml of beer), or information about a history of alcoholism, drug addiction, or drug abuse;
• Positive test for the presence of alcohol in exhaled air;

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (2)

State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"

Moscow, 117556, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of the Russian Federation

Moscow, 127473, Russia

Location

MeSH Terms

Interventions

canakinumab

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 1, 2024
• Study Start: September 6, 2022
• Primary Completion: March 17, 2023
• Study Completion: May 26, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)