A 2-part, Open Label, Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of Two Different Amlitelimab Drug Products After Administration of a Single Subcutaneous Dose in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Part 1: Maximum Plasma concentration observed (Cmax )
研究概览
简要总结
This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants.
Study details include:
The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).
详细描述
The study duration for a participant will be approximately 17 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, and laboratory tests
- •Body weight within 55 to 100 kg and body mass index (BMI) within the range 18-30 kg/m2 (inclusive)
- •Male or female of childbearing potential are required to either practice true abstinence consistent with their preferred and usual lifestyle or use highly effective contraceptive methods for the entire duration of the treatment until 4 months after the investigational medicinal product (IMP) dosing.
排除标准
- •Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, unless the investigator considers an abnormality to be not clinically significant.
- •Participants with a history of helminthic infection or invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, aspergillosis, irrespective of resolution.
- •Serious infections requiring hospitalization within 30 days prior to screening or any active infection requiring treatment during screening.
- •Current or past diagnosis of malignancies within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).
- •Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician.
- •Evidence of active or latent tuberculosis (TB XE ' TB ' \f Abbreviation \t 'tuberculosis ' ) as documented by medical history and examination; TB testing via a positive (not indeterminate) QuantiFERON TB Gold test
- •If female, pregnancy (defined as positive beta human chorionic gonadotropin [β-HCG] test), or lactating. - Received a live (attenuated) immunization within 12 weeks prior to inclusion or non-live immunization within 4 weeks prior to inclusion.
- •Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1 (Part1)
Participants will receive a single SC dose of amlitelimab DP1 on Day 1.
干预措施: Amlitelimab DP1 (Drug)
Group 2 (Part 2)
Participants will receive a single SC dose of amlitelimab DP1 on Day 1.
干预措施: Amlitelimab DP1 (Drug)
Group 3 (Part 2)
Participants will receive a single SC dose of amlitelimab DP2 on Day 1.
干预措施: Amlitelimab DP2 (Drug)
结局指标
主要结局
Part 1: Maximum Plasma concentration observed (Cmax )
时间窗: From Day1 up to Day92 (end of study [EOS])
Cmax after administration of a single SC dose of amlitelimab DP 1
Part 2: AUC of two different amlitelimab DPs (DP1 and DP2)
时间窗: From Day1 up to Day92 (EOS)
AUC after administration of a single SC dose of amlitelimab DP1 and DP 2
Part 2: Cmax of two different amlitelimab DPs (DP1 and DP2)
时间窗: From Day1 up to Day92 (EOS)
Cmax after administration of a single SC dose of amlitelimab DP 1 and DP2
Part 2: AUClast of two different amlitelimab DPs (DP1 and DP2)
时间窗: From Day1 up to Day92 (EOS)
AUClast after administration of a single SC dose of amlitelimab DP1 and DP 2
Part 1: Area under the curve from the time of dosing to the last measurable concentration (AUClast)
时间窗: From Day1 up to Day92 (EOS)
AUClast after administration of a single SC dose of amlitelimab DP 1
Part 1: Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
时间窗: From Day1 up to Day92 (EOS)
AUC after administration of a single SC dose of amlitelimab DP 1
次要结局
- Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)(From the signing of the informed consent form (ICF) up to Day92 EOS visit)