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临床试验/NCT05863442
NCT05863442招募中1 期

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

Turgut Ardika PTY LTD1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月10日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
120
试验地点
1
主要终点
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •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 -
  • •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.

排除标准

  • •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 -
  • •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.

研究组 & 干预措施

Soliris

Active Comparator

干预措施: Soliris 300 MG in 30 ML Injection (Drug)

TUR03

Experimental

干预措施: TUR03 300 MG in 30 ML Injection (Drug)

结局指标

主要结局

PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants

时间窗: Day 1 - Day 57

The primary endpoint for PK similarity is AUC(0-inf).

次要结局

  • AEs and AESI(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(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALT(Day 1 - Day 57)
  • Time to Cmax(Day 1 - Day 57)
  • Terminal half-life(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(Day 1 - Day 57)
  • Eculizumab serum concentration-time profile(Day 1 - Day 57)
  • Maximum serum concentration (Cmax)(Day 1- Day 57)
  • Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)(Day 1- Day 57)
  • Total serum clearance of drug after intravenous administration(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Hematology(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatinine(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALP(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Chloride(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Calcium(Day 1 - Day 57)
  • Volume of distribution during terminal phase after intravenous administration(Day 1 - Day 57)
  • Terminal elimination rate constant(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Urea(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(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Urobilinogen(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Ketones(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Prothrombin time(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - AST(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Sodium(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Albumin(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Phosphate(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)(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)(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(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(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Leukocytes(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(Day 1 - Day 57)
  • Changes in vital signs - Pulse rate(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(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(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Potassium(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Triglycerides(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Cholesterol(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - pH(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Nitrite(Day 1 - Day 57)
  • Changes in Electrocardiograms (ECG) - RR interval(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Protein(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Bilirubin(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Glucose(Day 1 - Day 57)
  • Changes in vital signs - Body Temperature(Day 1 - Day 57)
  • Changes in Electrocardiograms (ECG) - PR interval(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Specific gravity(Day 1 - Day 57)
  • Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Microscopy(Day 1 - Day 57)
  • Changes in vital signs - Blood Pressure(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)(Day 1 - Day 57)
  • PD profile of TUR03 and Soliris - AUEC(0-1344) CH50(Day 1 - Day 57)
  • Changes in Electrocardiograms (ECG) - Heart rate(Day 1 - Day 57)
  • Changes in Electrocardiograms (ECG) - QRS duration(Day 1 - Day 57)
  • Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Antidrug antibody titers(Day 1 - Day 57)
  • PD profile of TUR03 and Soliris - Tmin CH50(Day 1 - Day 57)
  • Changes in Electrocardiograms (ECG) - QT interval(Day 1 - Day 57)
  • Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Neutralizing antibodies (NAbs)(Day 1 - Day 57)
  • PD profile of TUR03 and Soliris - Emin CH50(Day 1 - Day 57)
  • Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 via physical examination(Day 1 - Day 57)
  • PD profile of TUR03 and Soliris - ABEC (0-1344) CH50(Day 1 - Day 57)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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