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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Ying Wang, PhD
- 전화번호: 086-18367124548
- 이메일: nancywangying@163.com
연구 장소
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국
- 모병
- First People's Hospital of Hangzhou
-
수석 연구원:
- Ying Wang, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
실험적: 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 |
|
실험적: 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 |
|
실험적: PART2: Group 4, 150mg, domen
single-dose, SC at domen, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
실험적: PART2: Group 5, 150mg, upper arms
single-dose, SC at upper arms, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
실험적: PART2: Group 6, 150mg, thihgs
single-dose, SC at thighs, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
실험적: PART2: Group 7, 300mg, domen
single-dose, SC at domen, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
실험적: PART2: Group 8, 300mg, upper arms
single-dose, SC at upper arms, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
실험적: PART2: Group 9, 300mg, thighs
single-dose, SC at thighs, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse events
기간: through study completion
|
PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion
|
|
Cmax
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
AUC
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: through study completion (approximately 140 days)
|
Number and percentage of participants with a positive neutralizing antibody (NAb) result. |
through study completion (approximately 140 days)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ying Wang, PhD, First People's Hospital of Hangzhou
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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