NCT07358156招募中1 期
A Randomised, Double-blind, Three-arm, Parallel Group, Single Dose, Phase 1 Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 519
- 试验地点
- 2
- 主要终点
- Maximum serum concentration (Cmax)
研究概览
简要总结
This is a randomised, double-blind, three-arm, parallel group, single-dose, Phase 1 comparative study of CKD-706, US-Dupixent, and EU-Dupixent in healthy adult participants.
详细描述
Dosing the CKD-706, US Dupixent, or EU-Dupixent 300 mg at Day 1. Blood samples for Pharmacokinetic analysis will be collected on Day 1 - 85. Blood sample for Pharmacodynimic and immunogenicity analysis will be collected on Day 1 - 85.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is capable of giving signed informed consent
- •Male and female healthy participant between 18 to 55 years of age (inclusive) at screening, with suitable veins for cannulation or repeated venipuncture.
- •Body-mass index between 18.5 - 29.9 kg/m2 (inclusive) with body weight ≥ 50 kg and < 95 kg at screening.
- •Participant agrees to be available for the entire duration of the study
- •All female participants must have a negative serum pregnancy test at the screening visit and on admission to the Clinical Unit (Day -1).
- •Female Participants:
- •A female participant is eligible to participate if she is not pregnant, not be lactating and not breastfeeding, and at least one of the following conditions applies
- •Male Participants • Male participants and their female spouse/partners who are of childbearing potential must be using 2 forms of birth control from screening until at least 3 months after the end of study intervention dose.
排除标准
- •Participant with history of any clinically important disease or disorder which, may either put the participant at risk during study.
- •Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalisation during the study period.
- •Participant with prior exposure to dupilumab (Dupixent or biosimilar dupilumab).
- •Participation in any interventional clinical trial or receipt of any investigational product within 30 days (or < 5 half-lives of investigational drug taken) prior to dosing.
- •Participant with current malignancy or within the past 5 years and suspected malignancy or undefined neoplasms.
- •Participant with history or presence of chronic gastrointestinal, hepatic, renal, or pancreatic disease or ongoing acute disease in these organs, or any other condition constituting a risk when taking the study intervention.
- •Participant with diagnosis or history of immunodeficiency or increased susceptibility to severe infections, or a clinically significant infection within 4 weeks of screening.
- •Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at screening or admission, as judged by the Investigator.
- •Participant with white blood cell count < lower limit of normal at screening or admission.
- •Participant with any clinically significant abnormal finding in vital signs as judged by the Investigator.
- •Any clinically significant abnormalities on 12-lead ECG at screening or admission (Day -1) to the Clinical Unit, as judged by the Investigator.
- •Participant with positive screen results for drugs of abuse or alcohol at screening or on admission to the Clinical Unit.
- •Known or suspected history of alcohol or illicit drug abuse or excessive intake of alcohol within 1 year of screening, as judged by the Investigator.
- •Participants who smoke more than 5 cigarettes per day or consume equivalent nicotine substitutes, including e-cigarettes or inability to refrain from smoking during the in-house stay period.
- •Participant has received live vaccine(s) or live attenuated vaccines within 1 month prior to screening or plans to receive such vaccines during the study.
- •Participant with known helminthic infection, or within 6 months prior to screening.
- •Participant has a positive test for human immunodeficiency virus antibody or positive results for Hepatitis B surface antigen, anti-hepatitis B core antibody or Hepatitis C virus antibody, except for vaccinated participants or participants with past but resolved hepatitis, at screening.
- •Participant is unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission on Day -1 and not consuming caffeine before any outpatient visits.
- •Participant with excess use of caffeine, which is defined as exceeding 500 mg caffeine/day (e.g., > 5 cups of coffee) within 14 days prior to administration of the study intervention.
- •Participant has donated blood (> 500 mL) or blood products within 56 days prior to admission.
- •Participant has used over-the-counter medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission until the End of Study visit.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to monoclonal or polyclonal antibodies. History of allergy or reaction to any formulation components of the study intervention.
- •Participant is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope, and possible consequences of the clinical study.
- •Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions.
- •Participant has previously been enrolled in this clinical study.
- •Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- •Involvement of any Chong Kun Dang Pharmaceutical, Parexel or study site employee or their close relatives.
研究组 & 干预措施
Arm 1
Experimental
173 healthy participants receiving one dose of investigational medical product
干预措施: CKD-706 (Drug)
Arm 2
Active Comparator
173 healthy participants receiving one dose of investigational medical product
干预措施: US-Dupixent (Drug)
Arm 3
Active Comparator
173 healthy participants receiving one dose of investigational medical product
干预措施: EU-Dupixent (Drug)
结局指标
主要结局
Maximum serum concentration (Cmax)
时间窗: Day 1 - 85.
Area under the concentration-time curve from time zero up to infinity (AUC0-inf)
时间窗: Day 1 - 85.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
时间窗: Day 1 - 85.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
3 期
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)NCT07303322Eurofarma Laboratorios S.A.372
招募中
1 期
Study of CM383 in Healthy SubjectsNCT07292688Keymed Biosciences Co.Ltd30
招募中
1 期
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary DiseaseCOPD (Chronic Obstructive Pulmonary Disease)COPDNCT07285122Atisama Therapeutics105
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
进行中（未招募）
1 期
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive DysfunctionNCT07304843Umecrine Cognition AB84