NCT03980080已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18 to 65 years (extremes included). Maximum two subjects aged between 60 and 65 (extremes included) are allowed per dose group.
- •Healthy volunteers (medically stable), as determined on the basis of medical history, vital signs, clinical laboratory testing, and general physical examination performed at screening and deemed appropriate by the Investigator.
- •Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations, as judged by the Investigator.
- •Weighs at least 50 kg and no more than 100 kg and has a Body Mass Index (BMI) within normal range: 19.0 ≤ BMI ≤ 30.0 kg/m².
- •Negative urine test for selected drugs of abuse at screening.
- •Negative alcohol breath test at screening.
- •Female subjects is postmenopausal, surgically sterile (having had a hysterectomy or bilateral oophorectomy) and/or is using a highly effective method of contraception (from 2 weeks before first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject <20% or 5 t1/2 whichever is longer).
- •Female subject has a negative pregnancy test at screening.
- •Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of a highly effective method of contraception (from the first study drug administration until 28 days after the last follow-up visit, when it is confirmed that the RO of the subject <20% or 5 t1/2 whichever is longer).
- •Willing to adhere to the prohibitions and restrictions specified in the protocol.
- •Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
- •Non-smoker or light smoker, i.e. smokes maximal 5 cigarettes (or 3 cigars or 3 pipe-full) per day, and ability and willingness to refrain from smoking during confinement and ambulant visits in the CPU.
排除标准
- •A history of any clinically significant (as determined by the Investigator) cardiac, endocrinology, hematology, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding non-melanoma skin cancer.
- •A known allergy, hypersensitivity, or intolerance to any of the excipients in the formulation of the study drug.
- •The subject has a history of severe allergic or anaphylactic reactions.
- •The suject has a history of consuming more than 14 units of alcoholic beverages per week for male subjects, and more than 10 units for females. Or a history of alcoholism, or drug/chemical/substance abuse within the past 2 years prior to screening.
- •Evidence or history of any clinically significant infections within the past 3 months.
- •Subject with known clinically relevant immunological disorders, or auto-immune disorders (e.g. rheumatoid arthritis, lupus erythematosus, scleroderma, etc...).
- •A positive hepatitis panel (including hepatitis B surface antigen [HBsAg] and anti-hepatitis C virus [HCV] antibodies [Abs]) or positive human immunodeficiency virus (HIV) antibody screens.
- •The subject has a supine systolic blood pressure (SBP) <90 or >149 mmHg and/or a diastolic blood pressure (DBP) <45 or >90 mmHg, and/or a pulse rate higher than 100 beats per minute (bpm) at screening (blood pressure measurements taken after subject has been resting in a supine position for a minimum of 5 minutes).
- •Pregnant or breastfeeding women.
- •The subject has received a live vaccine (excluding flu vaccination), within 30 days prior to study drug administration, or plan to receive this type of vaccine during the study.
- •The subject has received any systemic immunosuppressant agent, within 6 months prior to study drug administration.
- •The subject has received any antibody or biologic medicinal product, within 6 months prior to study drug administration.
- •The subject has received any systemic steroid, within 2 months prior to study drug administration.
- •Use of a prohibited therapy during the study.
- •Receipt of any investigational drug, within 30 days or 5 half-lives (whichever is longer) prior to the initial study drug administration.
- •The subject is participating in another clinical trial or has participated in another dose group of the current trial. Participation in non-interventional registries or epidemiological studies is allowed.
- •Having had a significant blood loss (including blood donation [>500 mL]) or a having had a transfusion of any blood product (within the past 60 days) or donated plasma (within 7 days prior to the initial study drug administration).
- •A condition that, in the opinion of the Investigator, could compromise their well-being or the course of the study, or prevent them from meeting or performing any study requirement.
研究组 & 干预措施
OSE-127: Part 1 (SAD), Cohort A & Cohort B
Experimental
干预措施: OSE-127 (Drug)
Placebo: Part 1 (SAD), Cohort A & Cohort B
Placebo Comparator
干预措施: Placebo (Drug)
OSE-127: Part 2 (MAD)
Experimental
干预措施: OSE-127 (Drug)
Placebo: Part 2 (MAD)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Findings in Physical Examinations Reported as Adverse Event
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as Adverse Event
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Findings in Telemetry Reported as Adverse Event
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Adverse Event
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) : Incidence of anti-drug antibody (ADA) formation
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
Part 1 (SAD) & Part 2 (MAD) :Number of Participants With Clinically Significant Change in vital signs Reported as Adverse Event
时间窗: 12 weeks (for Part 1); 19 weeks (for Part 2)
次要结局
- Part 1 (SAD) & Part 2 (MAD) : Trough serum Concentration observed at the end of the dosing interval [Ctrough](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Elimination half-life associated with the terminal rate constant (λz) [T1/2](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Time corresponding to the Cmax [Tmax](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : AUC extrapolated to infinity [AUCinf](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Average serum Concentration over the dosing interval [Cavg](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Area Under the serum concentration-time Curve from time zero till X days postdose [AUCτ](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Effect on total lymphocyte count(12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Maximum Plasma Concentration [Cmax](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : AUC calculated between time of administration and last quantifiable concentration [AUClast](12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : Accumulation Ratio [Rac].(12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : AUC over the dosing interval [AUC0-τ].(12 weeks (for Part 1); 19 weeks (for Part 2))
- Part 1 (SAD) & Part 2 (MAD) : CD-127 Receptor Occupancy [RO](12 weeks (for Part 1); 19 weeks (for Part 2))
研究者
研究点 (1)
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