HealthyPhase 1NCT05863442
Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants
A Phase 1 study testing Soliris 300 MG in 30 ML Injection and TUR03 300 MG in 30 ML Injection in people with Healthy, run by Turgut Ardika PTY LTD at 1 site in Australia.
Trial summary
This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Soliris 300 MG in 30 ML Injection and TUR03 300 MG in 30 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Apr 2023to 5 Oct 2024
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if ALL of the following criteria apply:
- Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Participants assigned male at birth who are ≥18 years and ≤45 years old at the time of signing the ICF.
- Body weight ≥50 kg and ≤90 kg and body mass index (BMI) ≥18.00 kg/m2 and ≤30.00 kg/m2 at Screening and Day -1.
- Participants must be healthy as determined by the Investigator, based on medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations at Screening and Day -1, as follows:
- Hematology and coagulation results within reference ranges.
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- Liver function panel analyte values ≤1.5 × upper limits of normal (ULN), which include aspartate transaminase, alanine transaminase, and total bilirubin (for participants with Gilbert's Syndrome, total bilirubin ≤3.0 × ULN is allowed if direct bilirubin is ≤50%), alkaline phosphatase, and gamma glutamyl transferase at Screening.
- Urinalysis within reference ranges or showing no clinically significant findings.
- NOTE: One repeat of clinical laboratory tests is allowed at the discretion of the Investigator.
- Participants must have documented evidence of prior complete vaccination with meningococcal vaccines against N. meningitidis serogroup B at any time and against serogroups A, C, W, and Y within 5 years prior to Screening in line with local immunization requirements or must agree to be vaccinated against N. meningitidis during the study.
- Nonsterilized participants with partners of childbearing potential must agree to take appropriate contraceptive measures (as described in Section 10.4) from Day 1 until 5 months after IP administration and refrain from donating sperm during this period. NOTE: Participants with pregnant partners are excluded.
- Nonsmoker or occasional smoker, ie, smokes ≤10 cigarettes (or equivalent of tobacco- or nicotine-containing products) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site.
- Ability and willingness to abstain from alcohol from 48 hours before admission to the study site on Day -1, during in-house observation at the study site until discharge, and for 24 hours prior to ambulatory visits.
Who cannot join
- Participants are excluded from the study if ANY of the following criteria apply:
- Known or suspected hereditary or acquired complement deficiency.
- History of meningococcal infection.
- History or evidence of a clinically significant disorder (including psychiatric disorders), condition, or disease that, in the opinion of the Investigator and Medical Monitor or designee, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. EXCEPTION: Fully resolved childhood asthma is not exclusionary.
- History of splenectomy.
- History of surgery or major trauma within 12 weeks of Screening, or surgery planned during the study.
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- A recent history (within 1 week prior to IP administration) or presence or suspicion of current active systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory condition, in the opinion of the Investigator.
- History of or current invasive malignancy (excluding basal or squamous cell carcinoma that has been fully resected with no evidence of metastatic disease for 1 year).
- History of ongoing seborrheic dermatitis or eczema.
- History of clinically significant headaches that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- History of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to IP administration.
- History of a drug- or food-induced severe hypersensitivity reaction (eg, immunologic or nonimmunologic anaphylaxis).
- Known hypersensitivity reaction to penicillin and/or cephalosporin that, in the opinion of the Investigator, would pose a risk to participant safety.
- Known hypersensitivity to any component of TUR03 or Soliris, murine proteins, or other monoclonal antibodies.
- Known hypersensitivity to any component of meningococcal vaccines, including those containing diphtheria toxoid, or a life-threatening reaction after previous administration of a vaccine containing similar components.
- Hypertension at Screening or Day -1 (defined as a systolic blood pressure [BP] >140 mm Hg and/or a diastolic BP >90 mm Hg, confirmed by a single repeat measurement that same day) or a history of hypertension requiring pharmacological intervention.
- Proteinuria at Screening or Day -1 (with a urine dipstick value of 1+ or above)..
- Tests positive for human immunodeficiency virus (HIV 1 and 2), hepatitis B virus surface antigen, hepatitis B core antibody, or hepatitis C virus.
- Tests positive for tuberculosis (TB) using the QuantiFERON®-TB Gold test at Screening or, if indeterminant result on the first test, tests positive or indeterminant on repeat QuantiFERON-TB Gold test.
- Positive screen for alcohol by breath test and/or potential drugs of abuse by urine drug screen at Screening or Day -1. NOTE: One repeat screen is allowed at the discretion of the Investigator.
- History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to Screening.
- Prior exposure to eculizumab or similar compounds (ie, a monoclonal antibody that specifically binds to the complement protein C5).
- Use of immunoglobulins or iron supplementation within 3 months prior to Screening.
- Use of any over-the-counter (OTC) medications, herbal remedies such as St. John's Wort extract, or prescription medications within 7 days or 5 half lives (whichever is longer) prior to IP administration. EXCEPTIONS: Vitamins, dietary supplements, and paracetamol (up to 4 g per day, but <1 g in 4 hours) for analgesia are not exclusionary.
- Use of other investigational drugs (or is currently using an investigational device) within 60 days or 5 half-lives (whichever is longer) prior to IP administration.
- Vaccination with a live vaccine within 30 days prior to IP administration, or vaccination with an inactivated vaccine or approved COVID-19 vaccine within 14 days prior to IP administration, or planning to get vaccinated during the study period. EXCEPTIONS: Receipt of required meningococcal vaccinations per protocol is not exclusionary.
- Veins unsuitable for venous blood collection.
- Donated blood (including blood products) or experienced loss of blood ≥500 mL within 30 days of Screening, or donated plasma within 7 days of Screening.
- Participant is a family member or employee of the Investigator or Sponsor.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Q-Pharm Pty Limited
Herston, Queensland
Complaints Officer, 1800 243 733, complaintsofficer@nucleusnetwork.com.au
Privacy Officer, privacyofficer@nucleusnetwork.com.au
About this study
Official title: A First-in-human, Randomized, Double-blind, Parallel-group Study to Evaluate the PK, Safety, Tolerability, Immunogenicity, and PD Profile of a Single Intravenous Dose of TUR03 Compared With Soliris® in Healthy Adult Male Participants
This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.
- Conditions
- Healthy
- Being tested
- Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection
- Keywords
- eculizumab, phase I, biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soliris 300 MG in 30 ML InjectionDrug
Active Comparator
TUR03 300 MG in 30 ML InjectionDrug
Investigational medicinal Product, eculizumab - Turgut
| Study group | Role | What they receive |
|---|---|---|
| Soliris | Active comparator | Not described Receives: Drug: Soliris 300 MG in 30 ML Injection |
| TUR03 | Experimental | Not described Receives: Drug: TUR03 300 MG in 30 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants
The primary endpoint for PK similarity is AUC(0-inf).
Measured: Day 1 - Day 57
Secondary outcomes (60)
Eculizumab serum concentration-time profile
Serum eculizumab concentrations will be listed and summarized using descriptive statistics by treatment group and nominal PK sampling time point. All serum eculizumab concentrations that are below the limit of quantification will be labeled as such in the concentration data listings. Individual and arithmetic mean (per treatment) concentration-time profiles will also be presented graphically.
Measured: Day 1 - Day 57
Maximum serum concentration (Cmax)
Observed concentration versus time data
Measured: Day 1- Day 57
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
AUC(0-last)
Measured: Day 1- Day 57
Time to Cmax
tmax
Measured: Day 1 - Day 57
Terminal half-life
t½
Measured: Day 1 - Day 57
Volume of distribution during terminal phase after intravenous administration
Vz
Measured: Day 1 - Day 57
Terminal elimination rate constant
Kel
Measured: Day 1 - Day 57
Total serum clearance of drug after intravenous administration
CL
Measured: Day 1 - Day 57
AEs and AESI
infusion-related reactions, meningococcal infections, and other serious systemic infections
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Hematology
Platelet count, Red blood cell count, Neutrophils, Hemoglobin, Lymphocytes, Hematocrit, Monocytes, Eosinophils, Mean corpuscular volume, Basophils, Mean corpuscular hemoglobin, Mean cell hemoglobin concentration will be measured to assess changes in hematological parameters in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - International normalized ratio
International normalized ratio (INR) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Activated partial thromboplastin time
Activated partial thromboplastin time (sec) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Prothrombin time
Prothrombin time (sec) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Urea
Urea (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Carbon dioxide (bicarbonate)
Carbon dioxide (bicarbonate)(mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatinine
Creatinine (mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - AST
AST (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALT
ALT (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALP
ALP (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Glucose (fasting)
Glucose (fasting)(mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Gamma glutamyl transferase
Gamma glutamyl transferase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total Protein
Total protein (g/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatine kinase
Creatine kinase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Potassium
Potassium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Lactate dehydrogenase
Lactate dehydrogenase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Sodium
Sodium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Albumin
Albumin (g/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Chloride
Chloride (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total and direct bilirubin
Total and direct bilirubin (mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Calcium
Calcium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Triglycerides
Triglycerides (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Phosphate
Phosphate (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Cholesterol
Cholesterol (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Leukocytes
Leukocytes, will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Red blood cells
Red blood cells (/hpf) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Protein
Protein (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - pH
pH will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Bilirubin
Bilirubin will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Nitrite
Nitrite will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Urobilinogen
Urobilinogen (EU/dl) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Specific gravity
Specific gravity will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Ketones
Ketones (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Glucose
Glucose (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Microscopy
Microscopic (if clinically indicated)(/hpf) analyses to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.
Measured: Day 1 - Day 57
Changes in vital signs - Blood Pressure
Systolic and diastolic blood pressure will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.
Measured: Day 1 - Day 57
Changes in vital signs - Pulse rate
Pulse rate will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.
Measured: Day 1 - Day 57
Changes in vital signs - Body Temperature
Body temperature (aural is preferred), will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.
Measured: Day 1 - Day 57
Changes in Electrocardiograms (ECG) - Heart rate
Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically calculates the heart rate. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.
Measured: Day 1 - Day 57
Changes in Electrocardiograms (ECG) - PR interval
Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures PR interval. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.
Measured: Day 1 - Day 57
Changes in Electrocardiograms (ECG) - RR interval
Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures RR interval. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.
Measured: Day 1 - Day 57
Changes in Electrocardiograms (ECG) - QRS duration
Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures QRS duration. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.
Measured: Day 1 - Day 57
Changes in Electrocardiograms (ECG) - QT interval
Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures QT interval. The QT interval corrected for heart rate by Fridericia's formula (QTcF interval) will be derived. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.
Measured: Day 1 - Day 57
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 via physical examination
Complete physical examination will be performed by a study-delegated registered physician at Screening and will include, at a minimum, assessments of general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory, system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. A brief physical examination will be performed at specified time points outlined in the SoA and will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). A symptom-directed physical examination, including areas with previously noted abnormalities and/or that are associated with any new complaints from the participant, will be performed at all other visits and at any time throughout the study, as clinically indicated.
Measured: Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Frequency of antidrug antibodies (ADAs)
Frequency of ADAs will be assessed. Serum samples will be screened for antibodies binding to eculizumab in TUR03 and Soliris. The detection and characterization of ADAs to eculizumab will be performed using validated immunoassay methods.
Measured: Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Antidrug antibody titers
Titers of ADAs will be assessed.
Measured: Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Neutralizing antibodies (NAbs)
The frequency of NAbs will be assessed in ADA-positive participants' sera. Subsequent to the confirmation of ADA-positivity, antibodies will be further characterized and evaluated for their ability to neutralize the activity of the IP (TUR03 and Soliris).
Measured: Day 1 - Day 57
PD profile of TUR03 and Soliris - ABEC (0-1344) CH50
Area between the baseline and effect curves for hemolytic complement activity from 0 to 1344 hours
Measured: Day 1 - Day 57
PD profile of TUR03 and Soliris - AUEC(0-1344) CH50
Area under the effect curve for hemolytic complement activity from 0 to 1344 hours
Measured: Day 1 - Day 57
PD profile of TUR03 and Soliris - Emin CH50
Minimum hemolytic complement activity from 0 to 1344 hours
Measured: Day 1 - Day 57
PD profile of TUR03 and Soliris - Tmin CH50
Time to minimum hemolytic complement activity from 0 to 1344 hours
Measured: Day 1 - Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start10 Apr 2023
- Primary completion23 Jul 2024 (estimated)
- Study completion5 Oct 2024 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turgut Ardika PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863442
- Sponsor's protocol ID
- TUR03-22-01
- Status last verified
- Nov 2023
- First submitted
- 17 Mar 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-blind, Parallel-group Study to Evaluate the PK, Safety, Tolerability, Immunogenicity, and PD Profile of a Single Intravenous Dose of TUR03 Compared With Soliris® in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT05863442
- Acronym / sponsor ID
- TUR03-22-01
- Conditions
- Healthy
- Keywords
- eculizumab, phase I, biosimilar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Turgut Ardika PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 23 Jul 2024 (estimated)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 18 May 2023 (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 designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soliris | Active comparator | Drug: Soliris 300 MG in 30 ML Injection |
| TUR03 | Experimental | Drug: TUR03 300 MG in 30 ML Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participants are eligible to be included in the study only if ALL of the following criteria apply:
- Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Participants assigned male at birth who are ≥18 years and ≤45 years old at the time of signing the ICF.
- Body weight ≥50 kg and ≤90 kg and body mass index (BMI) ≥18.00 kg/m2 and ≤30.00 kg/m2 at Screening and Day -1.
- Participants must be healthy as determined by the Investigator, based on medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations at Screening and Day -1, as follows:
Key exclusion criteria (29 listed)
- Known or suspected hereditary or acquired complement deficiency.
- History of meningococcal infection.
- History or evidence of a clinically significant disorder (including psychiatric disorders), condition, or disease that, in the opinion of the Investigator and Medical Monitor or designee, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. EXCEPTION: Fully resolved childhood asthma is not exclusionary.
- History of splenectomy.
- History of surgery or major trauma within 12 weeks of Screening, or surgery planned during the study.
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 |
|---|---|---|
| Soliris 300 MG in 30 ML InjectionActive Comparator | Drug | Soliris |
| TUR03 300 MG in 30 ML InjectionInvestigational medicinal Product, eculizumab - Turgut | Drug | TUR03 |
Primary outcome
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants
Time frame: Day 1 - Day 57
The primary endpoint for PK similarity is AUC(0-inf).
60 secondary outcomes
Eculizumab serum concentration-time profile
Time frame: Day 1 - Day 57
Maximum serum concentration (Cmax)
Time frame: Day 1- Day 57
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Time frame: Day 1- Day 57
Time to Cmax
Time frame: Day 1 - Day 57
Terminal half-life
Time frame: Day 1 - Day 57
Volume of distribution during terminal phase after intravenous administration
Time frame: Day 1 - Day 57
Terminal elimination rate constant
Time frame: Day 1 - Day 57
Total serum clearance of drug after intravenous administration
Time frame: Day 1 - Day 57
AEs and AESI
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Hematology
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - International normalized ratio
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Activated partial thromboplastin time
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Prothrombin time
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Urea
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Carbon dioxide (bicarbonate)
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatinine
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - AST
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALT
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALP
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Glucose (fasting)
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Gamma glutamyl transferase
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total Protein
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatine kinase
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Potassium
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Lactate dehydrogenase
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Sodium
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Albumin
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Chloride
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total and direct bilirubin
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Calcium
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Triglycerides
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Phosphate
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Cholesterol
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Leukocytes
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Red blood cells
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Protein
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - pH
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Bilirubin
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Nitrite
Time frame: Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Urobilinogen
Time frame: Day 1 - Day 57
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
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 Soliris 300 MG in 30 ML Injection and TUR03 300 MG in 30 ML Injection in people with Healthy, run by Turgut Ardika PTY LTD 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 13 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants (time frame: Day 1 - Day 57). 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 24 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.