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2023年4月10日

适应症Healthy

干预措施Soliris 300 MG in 30 ML Injection TUR03 300 MG in 30 ML Injection

概览

阶段: 1 期
干预措施: Soliris 300 MG in 30 ML Injection
疾病 / 适应症: Healthy
发起方: Turgut Ardika PTY LTD
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
状态: 招募中
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年4月10日

结束日期

2024年10月5日

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Turgut Ardika PTY LTD

责任方

Sponsor

入排标准

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.

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.

研究组 & 干预措施

Soliris

干预措施: Soliris 300 MG in 30 ML Injection

TUR03

干预措施: TUR03 300 MG in 30 ML Injection

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)