Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a)

NCT03614715 | Completed Phase 1 DMC

• 2 other identifiers: MC-CINNA-PKPD-012016-000139-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the trial is to investigate the biosimilarity of CinnoVex® by comparing its pharmacokinetics (PK) and pharmacodynamics (PD) to its originator, Avonex®, in a crossover manner in healthy female and male volunteers after administration of a single dose of 30 µg or 60 µg of Interferon beta-1a. The secondary objectives of the study are:

• To further compare the PK of CinnoVex® and Avonex®.
• To further compare the PD of CinnoVex® and Avonex®.
• To assess the safety of CinnoVex®.

Conditions

Bioequivalence; Healthy

Outcome Measures

Primary Outcomes (2)

• AUCt of IFNβ-1a

  Area under the plasma concentration curve from the time of IMP administration to the last observed concentration at last time point t, calculated using the linear trapezoidal rule

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

• Cmax of IFNβ-1a

  Maximum concentration of IFNβ-1a in plasma

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

Secondary Outcomes (21)

• tmax of IFNβ-1a

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

• t½ of IFNβ-1a

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

• AUCinf of IFNβ-1a

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

• VD

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

• MRT

  blood samples will be drawn prior to Investigational Medicinal Product administration, and then at the following times after dosing: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 14, 16, 18, and 24 hours, and mornings of Day 3, Day 4, Day 5, Day 6, and Day 8

Study Arms (2)

CinnaGen interferon beta-1a

EXPERIMENTAL

CinnoVex® (IFNβ-1a, Prefilled syringe produced by CinnaGen Company) in prefilled syringe in healthy volunteers. (Stage 1: 30 µg or 60 µg)(Stage 2: 30 µg)

Drug: Interferon Beta-1A

Biogen interferon beta-1a

ACTIVE COMPARATOR

Avonex® (IFNβ-1a, Prefilled syringe produced by Biogen Company) in prefilled syringe in healthy volunteers. (Stage 1: 30 µg or 60 µg)(Stage 2: 30 µg)

Drug: Interferon Beta-1A

Interventions

Interferon Beta-1A DRUG

A single dose of Interferon Beta-1A (Stage 1: 30 or 60 µg, stage 2: 30 µg) was administered IM to healthy subjects (cross over treatment)

Also known as: CinnoVex, Avonex

Biogen interferon beta-1a; CinnaGen interferon beta-1a

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent (IC) to participate in the trial, to comply with the trial procedures, and to abide by the trial restrictions.
• Be aged between 18 and 45 years with sufficient command of the Finnish language to be able to provide valid IC and to communicate adequately with the trial personnel.
• Have a Body Mass Index (BMI) between 18 and 28 kg/m2.
• Have good general health according to medical history, physical examination, ECG recording and clinical laboratory assessments.
• Female subjects of child-bearing potential must agree to use a medically accepted method of contraception during the trial and one month after the end of the trial. Acceptable methods of contraception include the following:
• Stable oral/transdermal/injectable hormonal contraceptive regimen without breakthrough uterine bleeding and condom/spermicide.
• Intrauterine device (inserted at least 2 months prior to Screening visit) used with spermicide/condom.
• Condom (male or female) with spermicide
• Vasectomy of the male partner in conjunction with condom or spermicide.

You may not qualify if:

• \) Be doubtful about his/her availability to complete the trial. 2) Have unsuitable veins for repeated venipuncture. 3) Be pregnant, or intend to become pregnant during the trial, or be lactating. 4) Have a history or evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological, psychiatric or other major disease.
• \) Have any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
• \) Have strong susceptibility to allergic reactions or history of allergy to any of the components of the IMP.
• \) Have clinically significant illness within 4 weeks before the start of the trial.
• \) Have any abnormal laboratory value or physical finding which may interfere with the interpretation of the test results or cause a health hazard for the subject if he/she takes part in the trial.
• \) Have any condition requiring regular concomitant medication or use of any medication that might affect the trial results or cause a health hazard to the subject within 2 weeks prior to the start of the trial; hormonal contraception and hormone replacement therapy are allowed.
• \) Have history of alcohol abuse or drug addiction or a positive result in the urine drug screen or breath alcohol test, or report consumption of more than 14 units of alcohol per week on a regular basis (1 unit = 4 cl of spirits of equivalent).
• \) Have a history of smoking \>10 cigarettes per day. 12) Participate in another drug trial or donation of blood within 90 days before first IMP administration in this trial.
• \) Have participated before in a clinical study investigating a Type I Interferon or have been treated with a Type I Interferon before.
• \) Be under anti-doping control. 15) Be at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Subjects must be excluded, if they report suicidal ideation with intent, with or without a plan or a method (e.g., positive response to items 4 or 5 in assessment of suicidal ideation on the C-SSRS) in the past two months or suicidal behaviour in the past six months.
• \) Have any other condition that in the opinion of the investigator would interfere with the evaluation of the trial results or constitute a health hazard for the subject.

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (1)

CRST Oy, Clinical Research Services Turku Itäinen Pitkäkatu 4 B, 3rd floor

Turku, Finland

Location

Related Publications (20)

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MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mika Scheinin, MD, PhD

  CRST, Itäinen Pitkäkatu 4B, FI-20520 Turku, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 3, 2018
• Study Start: November 27, 2017
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: January 10, 2020

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)