A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
NCT06481215
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
AO GENERIUM
Start date
2022-03-11
Number of sites
- 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.
- Short title
- A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
- Official title
- An Randomized Comparative Parallel-group Trial of the Safety, Pharmacokinetics, and Immunogenicity of the Drug GNR-068 and the Drug Stelara® After Their Single Subcutaneous Administration to Healthy Volunteers at a Dose of 45 mg
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2022-12-20
- First posted
- 2024-07-01
- Registry last updated
- 2024-07-01
- Primary completion date
- 2022-09-04
- Start date
- 2022-03-11
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AO GENERIUM
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06481215
- ClinicalTrials.gov ID
- NCT06481215
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- No masking
Sources for study design
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Timeframe: Day 84
Analysis of equivalence of AUC from time 0 (predose) to the last quantifiable data point and extrapolated to infinity of GNR-068 and Stelara®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Timeframe: Day 84
Analysis of equivalence of maximum concentration (Cmax) of GNR-068 and Stelara®
Proportion of volunteers with adverse events (AE)
Timeframe: Day 84
The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\])
Proportion of patients with Antidrug antibodies (ADA)
Timeframe: Day 84
Binding and neutralizing ADA will be identified
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- Volunteers should not have donated blood and its components 30 days before inclusion in the study and not become donors of blood and its products during the entire study and within 30 days after its completion.
- 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.
- Unwillingness or inability to comply with the recommendations prescribed by this protocol.
- Any planned surgical intervention during the study period.
- Reluctance to comply with contraceptive methods.
Sources for eligibility
- State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"Moscow, Russia
- 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 FederationMoscow, Russia
Sources for sites