Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.
The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.
Study details include:
- The study duration will be approximately up to 12 to 15 weeks.
- The treatment will be administered as a single dose on Day 1.
- The number of visits will be 14.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Trial Transparency email recommended (Toll free for US & Canada)
- 電話番号:option 6 800-633-1610
- メール:contact-us@sanofi.com
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent.
- Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight between 50.0 and 100.0 kg, inclusive.
- BMI between 18.0 and 32.0 kg/m2 (inclusive).
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP of ≥30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to any of the study interventions, or components thereof.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Regular smoking of more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking during the study (occasional smoker can be enrolled).
- Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- If female, pregnancy (defined as positive urine pregnancy test); breast-feeding.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Treatment A
Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1
|
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
他の名前:
|
|
実験的:Treatment B
Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1
|
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
時間枠:From Day 1 to Day 85 (end of study)
|
Cmax: Maximum concentration observed in serum
|
From Day 1 to Day 85 (end of study)
|
|
PK parameter in serum: AUClast of dupilumab
時間枠:From Day 1 to Day 85 (end of study)
|
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
|
From Day 1 to Day 85 (end of study)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs
時間枠:From Day -1 to Day 85.
|
From Day -1 to Day 85.
|
|
Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
時間枠:On Day 1, Day 43 and Day 85
|
On Day 1, Day 43 and Day 85
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Angel Lamas, MD、Clinical Pharmacology of Miami (CPMI)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PKM20425
- U1111-1331-0702 (レジストリ識別子:ICTRP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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