A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
연구 개요
상세 설명
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Sumida-ku, 일본, 130-0004
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion Criteria:
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Known hypersensitivity to any component of the study intervention.
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Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
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Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
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AST or ALT above 1.5 × ULN at screening.
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Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
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Hemoglobin or platelet count below the lower limit of normal at screening.
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White blood cell counts outside normal reference ranges.
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History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
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Any clinically significant abnormalities on 12-lead ECG at screening,
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Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
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Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
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Any condition that has the potential to increase clearance of the study intervention.
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Blood donation or collection as follows:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- Apheresis donation within 2 weeks prior to study drug administration.
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Absence of suitable veins for blood sampling and administration of study intervention.
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Any other condition that would compromise the safety of the participants.
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Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
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Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1. |
Participants will receive AZD7760 via IV infusion. |
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실험적: Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1. |
Participants will receive AZD7760 via IV infusion. |
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위약 비교기: Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1. |
Participants will receive matching placebo via IV infusion. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of Adverse Events (AEs)
기간: Day 1 to Day 181
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 181
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Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
기간: Day 1 to Day 361
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Day 1 to Day 361
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum observed serum (peak) drug concentration (Cmax)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Time to reach peak or maximum observed concentration following drug administration (tmax)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Terminal elimination half-life (t½λz)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Area under the concentration-time curve from time 0 to infinity (AUCinf)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution at steady state (Vss)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Volume of distribution based on the terminal phase (Vz)
기간: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Day 1 to Day 361
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Incidence of Anti-drug antibody (ADA)
기간: Day 1 to Day 361
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To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants |
Day 1 to Day 361
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공동 작업자 및 조사자
스폰서
협력자
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
이 연구와 관련된 용어
기타 연구 ID 번호
- D7480C00003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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