NCT07502534进行中（未招募）1 期
A Phase I, Randomized, Double-masked, Parallel-group Clinical Trial Evaluating the Bioequivalence and Safety of a Single Subcutaneous Dose of IBI3027 Monoclonal Antibody Injection Versus DUPIXENT® (Dupilumab) in Healthy Adult Chinese Male Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Peak drug concentration (Cmax)
研究概览
简要总结
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
Healthy volunteers will be randomly assigned in a 1:1 ratio to receive either IBI3027 or DUPIXENT?. The dosage for both groups is 300 mg. The entire study includes a 28-day screening period and a 56-day observation period (including 3 days of hospitalization). Randomization is stratified by body weight at baseline (D1) ≤ 70 kg vs. > 70 kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Follow the test procedures and voluntarily sign the informed consent form;
- •Male individuals aged 18 to 45 years (inclusive of the boundary value);
- •Weight between 63 and 75 kg (inclusive of the boundary value);
- •Agree to take contraceptive measures from the screening period to 120 days after the administration of the study drug.
排除标准
- •Those with a history of severe, progressive, and uncontrolled diseases in the liver, kidneys, cardiovascular system, nervous/psychiatric system, gastrointestinal tract, respiratory system, urinary system, endocrine system, hematologic system, etc.;
- •Individuals with a known history of recurrent or chronic infections, including but not limited to: chronic kidney infections, chronic thoracic infections (e.g., bronchiectasis), sinusitis, recurrent urinary tract infections, or infected open wounds, draining wounds, or skin infections;
- •Those with a known history of tuberculosis or clinical manifestations suspected of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.), or those with a positive IGRA test result;
- •Participants who had opportunistic infections within 180 days before screening (e.g., herpes zoster, active cytomegalovirus, Pneumocystis carinii, Histoplasma capsulatum, Aspergillus, Mycobacterium tuberculosis, etc.);
- •Participants who had an acute infection history within 14 days before screening;
- •Those with a known history of immune system diseases (e.g., thymic diseases, systemic lupus erythematosus);
- •Those with a history of malignancy;
- •Participants with abnormal vital signs and physical examination findings during the screening period, as judged clinically significant by the investigator;
- •Participants with abnormal laboratory test results during screening, including blood routine (absolute white blood cells count< 3.50×10^9/L, or > 9.50×10^9/L, absolute neutrophil count< 1.8×10^9/L, platelet count < 100×10^9/L, hemoglobin < 100 g/L), urinalysis, blood biochemistry [Alanine Transaminase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin (TBIL), Direct Bilirubin (DBIL) > 1.5×upper limit of normal (ULN), Creatinine (Cr) > ULN], coagulation function or thyroid function as judged clinically significant by the investigator;
- •Participants with abnormal chest X-ray (posteroanterior and lateral views) during the screening period, as judged clinically significant by the investigator;
- •Individuals testing positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, syphilis antibody (either specific or non-specific), hepatitis B surface antigen (HBsAg), or hepatitis B e antigen (HBeAg);
- •Those who had received IL-4Rα monoclonal antibody treatment in the past;
- •Use of any medication (including traditional Chinese medicine and vitamins) within 14 days prior to screening, or use of any medication less than five half-lives before the administration of study drug, whichever is longer;
- •Participants who had participated in other interventional clinical trials within 90 days before screening;
- •Participants who had undergone major surgery or been hospitalized for illness within 90 days before screening;
- •Participants who had lost blood, donated blood or received any blood product infusion ≥ 400 mL within 90 days before screening;
- •Participants who had received live vaccines within 180 days before screening, or were expected to receive live vaccines during the study period;
- •Participants who had a history of alcohol and/or drug abuse within 1 year before screening, or those with positive drug screening results;
- •Participants who had alcohol intake within 72 hours before screening or had a positive alcohol screening result;
- •Those suspected or confirmed to have an allergic constitution, or who have had previous allergic reactions to drugs or foods, with a clear history of allergies and/or who are allergic to the test drug or its components;
- •Participants who have a fertility plan from the screening period to 120 days after the administration of the investigational drug, or who are unwilling to take the contraceptive measures stipulated in the protocol during the trial;
- •Those with disabilities, bedridden, dependent on a wheelchair, or unable to take care of themselves;
- •Any other condition deemed by the investigator as rendering the participant unsuitable for participation in this clinical trial.
研究组 & 干预措施
IBI3027 treatment group
Experimental
The participants in this group will receive a 300 mg subcutaneous injection of IBI3027 on the first day.
干预措施: IBI3027 (Drug)
DUPIXENT® (dupilumab) treatment group
Active Comparator
The participants in this group will receive a 300 mg subcutaneous injection of DUPIXENT® (Dupilumab Injection) on the first day.
干预措施: DUPIXENT® (dupilumab) (Drug)
结局指标
主要结局
Peak drug concentration (Cmax)
时间窗: Days 1-57
Area under the plasma concentration-time curve (AUC0-∞).
时间窗: Days 1-57
次要结局
- clearance rate (CL/F)(Days 1-57)
- Anti-drug antibodies (ADA)(Days 1-57)
- Neutralizing antibodies (NAb)(Days 1-57)
- Elimination half-life (t1/2)(Days 1-57)
- The number and proportion of serious adverse events related to the experimental drug(Days 1-57)
- The number and proportion of treatment-related adverse events during the trial period(Days 1-57)
- Area under the plasma concentration-time curve (AUClast)(Days 1-57)
- volume of distribution (V/F)(Days 1-57)
研究者
研究点 (1)
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