健康な男性ボランティアにおける単回600 mg SC投与後のBmab3000とHerceptin Hylecta®の薬物動態、免疫原性、安全性および忍容性を評価する第1相比較試験
健康な男性ボランティアにおけるBmab3000とHerceptin Hylecta®の600 mg皮下注射単回投与後の薬物動態、免疫原性、安全性および忍容性を評価するための第I相、無作為化、二重盲検、二群並行デザイン比較試験
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
調査の概要
詳細な説明
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic & immunogenicity analyses and final laboratory evaluations.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Main Building: 264 Antigua Street,
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Christchurch、Main Building: 264 Antigua Street,、ニュージーランド
- New Zealand Clinical Research (NZCR)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
- All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
- Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
- Willing and able to sign the informed consent form (ICF).
Exclusion Criteria:
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
- History of relevant drug and/or food allergies.
- Positive urine drug and breath alcohol screen.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Donation or loss of blood prior to drug administration.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Bmab3000
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
|
アクティブコンパレータ：Herceptin Hylecta®
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
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 |
|---|---|---|
|
Cmax
時間枠：Day 1 to Day 91
|
Maximum observed concentration (Cmax) of drug Bmab 3000 |
Day 1 to Day 91
|
|
AUCo-∞
時間枠：Day 1 to Day 91
|
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) |
Day 1 to Day 91
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUCo-t
時間枠：Day 1 to Day 91
|
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification |
Day 1 to Day 91
|
|
Tmax
時間枠：Day 1 to Day 91
|
Time to maximum observed concentration |
Day 1 to Day 91
|
|
Vd/F
時間枠：Day 1 to Day 91
|
Volume of distribution |
Day 1 to Day 91
|
|
Cl/F
時間枠：Day 1 to Day 91
|
drug clearance |
Day 1 to Day 91
|
|
t1/2
時間枠：Day 1 to Day 91
|
Apparent terminal elimination half-life |
Day 1 to Day 91
|
|
AUC% extrapolation
時間枠：Day 1 to Day 91
|
% of the AUC that has been derived after extrapolation |
Day 1 to Day 91
|
|
λz
時間枠：Day 1 to Day 91
|
Elimination rate constant |
Day 1 to Day 91
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety_ Adverse Reactions
時間枠：Baseline to Day 91
|
Adverse Events and Adverse Reactions during the Treatment Period |
Baseline to Day 91
|
|
Safety_ Injection-site Reactions
時間枠：Day 1 to Day 91
|
Injection-site Reactions |
Day 1 to Day 91
|
|
Immunogenicity
時間枠：Day 1 to Day 91
|
Developing Antidrug Antibodies |
Day 1 to Day 91
|
|
Immunogenicity
時間枠：Day 1 to Day 91
|
Developing Neutralizing Antibodies |
Day 1 to Day 91
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Dr Cory Sellwood, MBBS、New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
- 主任研究者：Dr Leanne Barnett, MBBS、New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- BIO-TRASTU-103
- U1111-1329-7865 (その他の識別子：World Health Organization (WHO))
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?
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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