HealthyPhase 1NCT03722329
Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects
A Phase 1 study testing Eculizumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.
Trial summary
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2018to 8 Apr 2019
- 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
- Written informed consent
- Have a body weight between 70-95 kg and a body mass index between 20.0-29.9 kg/m²
- Have systolic blood pressure (SBP) ≤ 140 and ≥ 90 mmHg, diastolic blood pressure (DBP) ≤ 95 and ≥ 45 mmHg, and pulse rate ≥ 40 and ≤ 100 beats per minute or assessed as not clinically significant
- Have physical examination and 12-lead ECG results without clinically significant finding at Screening and Day -1 visits
- Non-smoker or smoker whose daily smoking does not exceed 10 cigarettes, 3 cigars, or 3 pipes for at least 30 days prior to Screening visit. Subjects should agree to abstain from smoking while resident at the clinical study site.
- Willing to receive vaccination against N. meningitidis at least 14 days prior to IP administration
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- Male subjects must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception unless their partner is infertile from the time of IP administration until 5 months after IP administration
- Must be willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations
- Have competence in speaking, writing and comprehending the local language where the study is conducted
Who cannot join
- Have a history/presence of clinically significant atopic allergy, allergic/hypersensitive reactions, or known or suspected clinically relevant drug hypersensitivity to eculizumab or its excipients
- Contraindication for IP or non-IP to be used in the study
- History of N. meningitidis infection
- Known or suspected hereditary or acquired complement deficiency
- Clinically significant active infection within 28 days before IP administration
- Any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory condition
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- Have previously been exposed to eculizumab (Soliris and its biosimilar)
- Previous treatment with a monoclonal antibody or fusion protein within 9 months prior to IP administration and/or have an evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein
- Have previously been exposed to an immunosuppressive agent or biological agent (any other than a monoclonal antibody or fusion protein) within 120 days prior to IP administration
- Any of the following abnormal laboratory values at Screening and Day -1 visits:
- Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 × ULN
- Serum C-reactive protein ≥ 10 mg/L
- Serum creatinine > 1.5 × ULN
- Whole blood cell count < 3000/mm3, absolute lymphocyte count < 800/mm3, and/or absolute neutrophil count ≤ 1500/mm3
- Any other laboratory abnormalities assessed as clinically significant by the Investigator
- Positive test result for hepatitis B surface antigen and/or hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus at Screening
- Surgery within 90 days prior to IP administration, and/or operation during study period
- Average intake of alcoholic beverages of more than 21 units/week for males and 14 units/week for females
- Drug abuse or a positive urinary drug screening result
- Have any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study, within 14 days prior to IP administration
- Donated >100 mL blood or plasma within 28 days prior to IP administration
- Subject directly involved in the conduct of the clinical study
- Vulnerable subjects
- Pregnant or nursing (lactating) women
Trial locations and contacts
1 site in 1 country.
Germany1 site
PAREXEL International GmbH, Early Phase Clinical Unit - Berlin
Berlin, 14050
About this study
Official title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
- Conditions
- Healthy
- Being tested
- Eculizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Eculizumab Injection. 300 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| SB12 | Experimental | SB12 (proposed eculizumab biosimilar) Receives: Drug: Eculizumab |
| EU Soliris | Active comparator | EU sourced Soliris (eculizumab) Receives: Drug: Eculizumab |
| US Soliris | Active comparator | US sourced Soliris (eculizumab) Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under the concentration-time curve from time zero to infinity
Measured: Day 1 to Day 64
Secondary outcomes (12)
AUClast
Area under the concentration-time curve from time zero to the last quantifiable concentration
Measured: Day 1 to Day 64
Cmax
Maximum observed serum concentration
Measured: Day 1 to Day 64
Tmax
Time to reach Cmax
Measured: Day 1 to Day 64
Vz
Volume of distribution during terminal phase
Measured: Day 1 to Day 64
λz
Terminal rate constant
Measured: Day 1 to Day 64
T1/2
Terminal half-life
Measured: Day 1 to Day 64
Clearance
Total body clearance
Measured: Day 1 to Day 64
%AUCextrap
Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity
Measured: Day 1 to Day 64
Incidence of Treatment-Emergent Adverse Events
Experience at least 1 treatment-emergent adverse event
Measured: Day 1 to Day 64
Incidence of Serious Adverse Events
Experience at least 1 serious adverse event
Measured: Day 1 to Day 64
Incidence of ADA
Incidence of anti-drug antibodies
Measured: Day 1 to Day 64
Incidence NAb
Incidence neutralising antibodies
Measured: Day 1 to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start13 Nov 2018
- Primary completion29 Mar 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, MD, Principal investigator, PAREXEL International GmbH, Early Phase Clinical Unit - Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722329
- Sponsor's protocol ID
- SB12-1001
- Status last verified
- Jan 2020
- First submitted
- 24 Oct 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03722329
- Acronym / sponsor ID
- SB12-1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SB12 | Experimental | Drug: EculizumabSB12 (proposed eculizumab biosimilar) |
| EU Soliris | Active comparator | Drug: EculizumabEU sourced Soliris (eculizumab) |
| US Soliris | Active comparator | Drug: EculizumabUS sourced Soliris (eculizumab) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Written informed consent
- Have a body weight between 70-95 kg and a body mass index between 20.0-29.9 kg/m²
- Have systolic blood pressure (SBP) ≤ 140 and ≥ 90 mmHg, diastolic blood pressure (DBP) ≤ 95 and ≥ 45 mmHg, and pulse rate ≥ 40 and ≤ 100 beats per minute or assessed as not clinically significant
- Have physical examination and 12-lead ECG results without clinically significant finding at Screening and Day -1 visits
- Non-smoker or smoker whose daily smoking does not exceed 10 cigarettes, 3 cigars, or 3 pipes for at least 30 days prior to Screening visit. Subjects should agree to abstain from smoking while resident at the clinical study site.
Key exclusion criteria (24 listed)
- Have a history/presence of clinically significant atopic allergy, allergic/hypersensitive reactions, or known or suspected clinically relevant drug hypersensitivity to eculizumab or its excipients
- Contraindication for IP or non-IP to be used in the study
- History of N. meningitidis infection
- Known or suspected hereditary or acquired complement deficiency
- Clinically significant active infection within 28 days before IP administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EculizumabEculizumab Injection. 300 mg, single dose | Drug | EU Soliris, SB12, US Soliris |
Primary outcome
AUCinf
Time frame: Day 1 to Day 64
Area under the concentration-time curve from time zero to infinity
12 secondary outcomes
AUClast
Time frame: Day 1 to Day 64
Cmax
Time frame: Day 1 to Day 64
Tmax
Time frame: Day 1 to Day 64
Vz
Time frame: Day 1 to Day 64
λz
Time frame: Day 1 to Day 64
T1/2
Time frame: Day 1 to Day 64
Clearance
Time frame: Day 1 to Day 64
%AUCextrap
Time frame: Day 1 to Day 64
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 64
Incidence of Serious Adverse Events
Time frame: Day 1 to Day 64
Incidence of ADA
Time frame: Day 1 to Day 64
Incidence NAb
Time frame: Day 1 to Day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainard Fuhr, MD principal investigator
PAREXEL International GmbH, Early Phase Clinical Unit - Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eculizumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 1 site in Germany.
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 9 inclusion and 24 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 9 Jan 2020. 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 Germany. 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?
AUCinf (time frame: Day 1 to Day 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2020.