A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers

NCT06481215 | Completed Phase 1

• 1 other identifier: UKM-PS-I
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.

Conditions

Healthy Volunteers

Keywords

ustekinumab; humanized monoclonal antibodies; safety; pharmacokinetics; equivalence; biosimilar; p40 subunit; IL-23; IL-12

Outcome Measures

Primary Outcomes (2)

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

  Analysis of equivalence of AUC from time 0 (predose) to the last quantifiable data point and extrapolated to infinity of GNR-068 and Stelara®

  Day 84

• Pharmacokinetics: Peak Plasma Concentration (Cmax)

  Analysis of equivalence of maximum concentration (Cmax) of GNR-068 and Stelara®

  Day 84

Secondary Outcomes (2)

• Proportion of volunteers with adverse events (AE)

  Day 84

• Proportion of patients with Antidrug antibodies (ADA)

  Day 84

Study Arms (2)

GNR-068 (JSC GENERIUM, Russia)

EXPERIMENTAL

ustekinumab biosimilar

Biological: GNR-068

Stelara® (manufacturer Silag AG, Switzerland, holder of authorisation Johnson & Johnson)

ACTIVE COMPARATOR

ustekinumab

Biological: Stelara®

Interventions

GNR-068 BIOLOGICAL

The investigational product GNR-068 was administered as a subcutaneous injection at a single dose of 45 mg.

Also known as: ustekinumab biosimilar

GNR-068 (JSC GENERIUM, Russia)

Stelara® BIOLOGICAL

The reference product Stelara® was administered as a subcutaneous injection at a single dose of 45 mg.

Also known as: ustekinumab

Stelara® (manufacturer Silag AG, Switzerland, holder of authorisation Johnson & Johnson)

Eligibility Criteria

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

You may qualify if:

• Men aged 18 to 45 years (inclusive) at the time of signing the Informed Consent Form.
• Diagnosis of "healthy" based on clinical and biochemical blood tests, urine tests, physical examination results, measurements of vital signs, electrocardiography and fluorography results.
• Availability of written informed consent obtained from the volunteer before the start of any procedures related to the study.
• Body weight from 60 to 90 kg inclusive.
• Body mass index 18.5-30 kg/m2 inclusive.
• Agreement to adhere to adequate methods of contraception during the entire period of participation in the study.

You may not qualify if:

• Use of drugs based on monoclonal antibodies for 1 year before drug administration.
• Vaccination (with any vaccine) within 30 days before signing the informed consent and/or the need for vaccination during the study period.
• A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
• History of an autoimmune disease.
• A history of a disease associated with the accumulation of immune complexes (including serum sickness).
• History of cancer.
• The presence of chronic diseases of the cardiovascular, bronchopulmonary (including bronchospastic diseases), neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, and mental illnesses.
• Acute infectious diseases less than 4 weeks before signing the informed consent.
• Blood donation or blood loss (450 ml of blood or more) less than 30 days before the start of the study.
• Participation in clinical trials of drugs less than 3 months before signing the informed consent.
• Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol) or anamnestic information about alcoholism, drug addiction, or drug abuse in the anamnesis.
• Positive test for the presence of alcohol in exhaled air.
• Smoking more than 10 cigarettes a day.
• Drug dependence and a positive urine test for the content of narcotic and potent drugs.
• Positive test results for hepatitis B or C, HIV or syphilis.

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

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• 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: March 11, 2022
• Primary Completion: September 4, 2022
• Study Completion: December 20, 2022
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)