A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
A Study of HB0017 Injection to Investigate PK After Subcutaneous Administration at Different Injection Sites in Healthy Volunteers, and to Evaluate Its Safety, Tolerability, and Pharmacokinetics in Low-body-weight Healthy Subjects
The goal of this clinical trial is to (PART 1) to evaluate the safety and tolerability of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.
調査の概要
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：Ying Wang, PhD
- 電話番号：086-18367124548
- メール：nancywangying@163.com
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 募集
- First People's Hospital of Hangzhou
-
主任研究者：
- Ying Wang, PhD
-
-
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:
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and BMI within 18~30（kg/m2）(including margin).
- Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs.
Exclusion Criteria:
- Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;
- History of psychiatric disorders.
- At screening, positive for any of the following in virological testing: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis test.
- At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis.
- Prior expose to anti-IL-17 or anti-IL-17 receptor antibody.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention.
- Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;
- Subjects deemed unsuitable for participation in this clinical trial by the investigator.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PART1: Group 1,75mg
single-dose, SC, HB0017 75 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
実験的：PART1: Group 2, 150mg
single-dose, SC, HB0017 150 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
実験的：PART1: Group 3, 300mg
single-dose, SC, HB0017 300 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
実験的：PART2: Group 4, 150mg, domen
single-dose, SC at domen, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
実験的：PART2: Group 5, 150mg, upper arms
single-dose, SC at upper arms, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
実験的：PART2: Group 6, 150mg, thihgs
single-dose, SC at thighs, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
実験的：PART2: Group 7, 300mg, domen
single-dose, SC at domen, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
実験的：PART2: Group 8, 300mg, upper arms
single-dose, SC at upper arms, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
実験的：PART2: Group 9, 300mg, thighs
single-dose, SC at thighs, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
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 |
|---|---|---|
|
Adverse events
時間枠：through study completion
|
PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion
|
|
Cmax
時間枠：From pre-dosing to 140 days post-dosing
|
PART 2:Cmax was the maximum observed plasma concentration directly observed from data. Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. |
From pre-dosing to 140 days post-dosing
|
|
AUCinf
時間枠：From pre-dosing to 140 days post-dosing
|
PART 2 : AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits).Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. |
From pre-dosing to 140 days post-dosing
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUC
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Area under the plasma concentration-time curve, reflecting total systemic drug exposure. |
From pre-dosing to 140 days post-dosing
|
|
Cmax
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Maximum observed plasma concentration after drug administration. |
From pre-dosing to 140 days post-dosing
|
|
Tmax
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Time to reach the maximum observed plasma concentration after drug administration. |
From pre-dosing to 140 days post-dosing
|
|
Vz
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Apparent volume of distribution during the terminal elimination phase; a theoretical volume relating the amount of drug in the body to the plasma concentration. |
From pre-dosing to 140 days post-dosing
|
|
CL
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Volume of plasma cleared of drug per unit time, reflecting total systemic clearance. |
From pre-dosing to 140 days post-dosing
|
|
t1/2
時間枠：From pre-dosing to 140 days post-dosing
|
PART 1: Time required for plasma drug concentration to decrease by 50% during the terminal elimination phase. |
From pre-dosing to 140 days post-dosing
|
|
Adverse events
時間枠：through study completion (approximately 140 days)
|
PART 2: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion (approximately 140 days)
|
|
ADA
時間枠：through study completion (approximately 140 days)
|
Number and percentage of participants with a positive anti-drug antibody (ADA) result. |
through study completion (approximately 140 days)
|
|
Nab
時間枠：through study completion (approximately 140 days)
|
Number and percentage of participants with a positive neutralizing antibody (NAb) result. |
through study completion (approximately 140 days)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ying Wang, PhD、First People's Hospital of Hangzhou
研究記録日
主要日程の研究
研究開始 (実際)
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
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