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PharmacokineticsPhase 1NCT03522012

Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers

A Phase 1 study testing Tocilizumab in people with Pharmacokinetics, run by Mycenax Biotech Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg in healthy volunteers (hereafter referred to… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteAustralia
Study dates
17 Oct 2017to 20 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing to provide written informed consent prior to performing study-related procedures.
  • Healthy male or female aged between 18 to 55 years, inclusive.
  • A body mass index between 18 to 30 kg/m2, inclusive.
  • Medically healthy with clinically insignificant results (e.g., medical history, electrocardiograms [ECGs], and physical examination) as judged by the Principal Investigator at Screening/Day 1 (admission to study center).
  • All laboratory results including, but not restricted to, complete blood counts, liver function, and lipid profile should be within the normal range or clinically insignificant as judged by the Investigator at Screening/Day 1 (admission to study center). An abnormal laboratory result considered to be erroneous, may be repeated once during Screening at the discretion of the Investigator.
  • Have systolic blood pressure ≤140 and ≥90 mmHg, diastolic blood pressure ≤90 and ≥50 mmHg, and a heart rate ≥40 and ≤100 beats per minute at Screening/Day 1 (admission to study center).
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  • Has to agree to abstain from alcohol intake 48 hours before administration of the study drug and during the inpatient period of the study.
  • Negative urine drug screen/alcohol breathylzer test at Screening/Day 1 (admission to study center).
  • Non-smokers or social smokers (defined as less than 10 cigarettes per week). No current use of any nicotine containing product. Cotinine levels ≤5 ng/mL.
  • Willing to abstain from sexual intercourse or use 2 methods of contraception (both male and female partners) as defined in the protocol for 3 months after study drug administration.
  • Female subjects who are using oral hormonal contraceptives must be willing to use, with their partner, 2 methods of contraception as defined as defined in the protocol.
  • Has to agree to not donate sperm or ova for at least 3 months after study drug administration.
  • Subjects who are negative for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibodies, human immunodeficiency virus I and II, as well as tuberculosis (TB) tests at Screening.
  • Did not receive a blood transfusion within 4 weeks prior to study drug administration, donate 400 mL or more blood within 8 weeks prior to study drug administration or donate plasma within 4 weeks prior to study drug administration and agrees to not make blood donations, including red blood cells, plasma, platelets, or whole blood for the duration of the study and for 3 months after study drug administration.
  • Able to be compliant with the protocol and attend all scheduled visits.
  • Has to agree to not consume any caffeine and/or xanthine products from 24 hours before admission to the study center until 48 hours after study drug administration.
  • Not have consumed grapefruit and/or grapefruit containing products, Seville oranges or quinine (tonic water) from 24 hours before admission to the study center until after the last sample has been collected for the study.

Who cannot join

  • Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
  • Have been treated with IV antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Screening.
  • History of TB infection, active TB or latent TB infection, or recent exposure to a person with active TB.
  • Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to Screening.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease.
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  • Evidence of active malignant disease, malignancies diagnosed within the previous 2 years (except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 2 years.
  • Impaired liver function as determined by:
  • Serum alanine aminotransferase and/or aspartate aminotransferase >1.5 x upper limit of normal (ULN) at Screening or admission to the study center. Subjects with values between ULN and 1.5 x ULN may be included in the study if considered not clinically significant by the Investigator.
  • Current or past history of diverticulitis or biliary obstruction.
  • Presence of proteinuria (other than trace amounts i.e., +, ++/+++) at Screening or admission to the study center.
  • Administration of an investigational product in another study within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening, or are currently participating in another clinical study of an investigational drug, or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
  • Use of any prescription or over-the-counter medication (with the exception of contraceptive medication in females and paracetamol) within 7 days of Screening and for the duration of participation in the study. This includes the use of any NSAIDs (including aspirin) within 28 days before study drug administration and for the duration of participation in the study.
  • Intake of herbal drugs or dietary supplements excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 28 days prior to study drug administration, unless agreed as not clinically relevant by the Investigator and Sponsor.
  • Regular alcohol consumption of >14 (female subjects) or >21 (male subjects) units of alcohol per week at the time of Screening (1 unit = 150 mL of wine or 360 mL of beer or 45 mL of 40% alcohol).
  • Failure to satisfy the Principal Investigator of fitness to participate for any other reason.
  • Female subjects who are pregnant, trying to become pregnant, or lactating.
  • Subjects who have a history of relevant drug hypersensitivity or hypersensitivity to the active substance or to any of the excipients.
  • Inability to undergo venipuncture and/or tolerate venous access.
  • Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol).
  • Involvement in the planning and/or conduct of the study (applies to the Sponsor, Contract Research Organizations, and study center staff, etc.).
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Any live virus vaccination or planned vaccination within 28 days before Screening and for the duration of participation in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: Phase I, Double-Blind, Randomized, Three-Arm, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest dose, the same has been selected for the study.

Being tested
Tocilizumab
Keywords
Pharmacokinetics, Tocilizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called ACTEMRA

    Tocilizumab is a recombinant human monoclonal antibody of the immunoglobulin G1 subclass, directed against the IL-6 ligand specific receptor. By preventing the binding of IL-6 to its receptor, tocilizumab inhibits the biological activity of IL-6. Tocilizumab was approved by the US Food and Drug Administration (4 mg/kg with an increase to 8 mg/kg based upon clinical response) for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to one or more tissue necrotizing factor (TNF) antagonist therapies. Tocilizumab is currently approved in 95 countries for the treatment of adult onset moderate to severe rheumatoid arthritis.

Study groups in NCT03522012
Study groupRoleWhat they receive
LusiNexExperimental4 mg/kg, single-dose IV infusion (Mycenax tocilizumab)
Receives: Drug: Tocilizumab
RoActemraActive comparator4 mg/kg, single-dose IV infusion (RoActemra; tocilizumab marketed in EU )
Receives: Drug: Tocilizumab
ActemraActive comparator4 mg/kg, single-dose IV infusion (Actemra; tocilizumab marketed in US)
Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics

    Area under concentration-time curve from time 0 (predose) extrapolated to infinity (AUC(0-∞)).

    Measured: 2 months

Secondary outcomes (10)

  1. Cmax

    Maximum concentration (Cmax)

    Measured: 2 months

  2. tmax

    Time to reach maximum concentration (tmax)

    Measured: 2 months

  3. AUC(0-t)

    Area under concentration-time curve from time 0 (predose) to the last quantifiable data point (AUC(0-t))

    Measured: 2 months

  4. t1/2

    Terminal half-life (t1/2)

    Measured: 2 months

  5. Vss

    Volume of distribution at steady-state

    Measured: 2 months

  6. Vd

    Volume of distribution (Vd)

    Measured: 2 months

  7. CL

    Systemic clearance (CL)

    Measured: 2 months

  8. Kel

    Elimination rate constant (Kel)

    Measured: 2 months

  9. AEs

    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])

    Measured: 2 months

  10. antidrug antibodies

    means of the occurrence of antidrug antibodies (ADA)

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start17 Oct 2017
  3. Primary completion26 Sep 2018
  4. Study completion20 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522012
Sponsor's protocol ID
LusiNEX-HV-PK-001
Status last verified
Nov 2018
First submitted
11 Apr 2018
Last updated
26 Feb 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tocilizumab in people with Pharmacokinetics, run by Mycenax Biotech Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03522012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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