Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
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.
- 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.
EXCLUSION CRITERIA
Exclusion Criteria:
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.
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Healthy
Age
18 - 45
Phase
PHASE1
Participants Needed
120
Est. Completion Date
Oct 5, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Turgut Ardika PTY LTD
ClinicalTrials.gov NCT Identifier
NCT05863442
Study Number
TUR03-22-01
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