성인 참가자를 대상으로 위약과 비교하여 VXX-401의 안전성, 내약성, 면역원성 및 약력학을 조사하기 위한 연구
건강한 성인에서 VXX-401의 안전성, 내약성, 면역원성 및 약력학을 평가하기 위한 1상, 최초, 무작위, 이중 맹검, 위약 대조, 용량 증량 연구
This first-in-human (FIH) study of VXX-401, an anti-PCSK9 peptide-based immunotherapeutic candidate, is designed to assess the safety, tolerability, immunogenicity, and pharmacodynamics (PD) of VXX-401 and to determine an optimal dose regimen for LDL-C lowering in subsequent clinical trials.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This is multisite, multidose regimen, phase 1, first-in-human study of VXX-401, a synthetic peptide-based active immunotherapy candidate for preventing and treating hypercholesterolemia. The study will include Screening, Treatment, and Follow-up Periods. This study will enroll participants who are naïve to statin use. Each cohort from A to D is planned to randomize approximately 12 participants to receive doses of VXX-401 or placebo in a 3:1 ratio. Cohorts E and F will dose approximately 8 participants in each cohort to receive doses of VXX-401. No participants will be administered placebo in Cohorts E and F. It is planned to test up to 6 dose regimens of VXX-401, administered by IM injection into the deltoid muscle (and additionally in the thigh for the first dose in Cohorts E-F.). All eligible participants will receive a priming regimen at Week 0 (Baseline, Day 1), Week 4, and Week 12, in Cohorts A, C, E and F, and additionally at Week 8 in Cohorts B and D. The last dose administration will be at Week 12.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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New South Wales
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Brookvale, New South Wales, 호주
- Northern Beaches Clinical Research
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Miranda, New South Wales, 호주
- Sutherland Shire Clinical Research
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Sydney, New South Wales, 호주
- Emeritus Research
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Queensland
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Morayfield, Queensland, 호주
- University of the Sunshine Coast (USC)
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Victoria
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Melbourne, Victoria, 호주
- Emeritus Research
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female participants aged 18 to 75 years old, inclusive, at time of informed consent.
- LDL-C level = 2.59 mmol/L - 4.89mmol/L
- Body mass index between 18 and 35 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
- Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
- Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice at least one form of highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose. Female participants must refrain from donating reproductive tissue during this same period.
Exclusion Criteria:
- Subjects considered high risk or very high risk for ASCVD and requiring immediate treatment with LLT according to the clinical judgement of the investigator.
- History of confirmed anergy (i.e., not able to mount an immunological response) or history of immunization failure in the 5 years prior to the Screening Visit.
- Presence of fever >38°C or other signs or symptoms of acute disease within 1 week before the Screening and/or Visit 1; Screening and/or Visit 1 may be rescheduled at the discretion of the Investigator but must occur within the 4-week window.
- Known disturbance of coagulation or medication (see prohibited medications criterion below); bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Triglycerides > 5.65 mmol/L
- Has a history of clinically significant medical disorder or psychiatric conditions, which in the opinion of the investigator may compromise the participant's safety and ability to comply with study procedures or abide by study restrictions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: VXX-401 Cohort A
VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12 |
A synthetic PCSK9 peptide-based immunotherapy |
|
실험적: VXX-401 Cohort B
VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12 |
A synthetic PCSK9 peptide-based immunotherapy |
|
실험적: VXX-401 Cohort C
VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12 |
A synthetic PCSK9 peptide-based immunotherapy |
|
실험적: VXX-401 Cohort D
VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12 |
A synthetic PCSK9 peptide-based immunotherapy |
|
위약 비교기: Placebo Cohort A and C
Placebo administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12 |
Normal saline |
|
위약 비교기: Placebo Cohort B and D
Placebo administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12 |
Normal saline |
|
실험적: VXX-401 Cohort E
VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 100 mcg administered by intramuscular (IM) injection at Week 4 and Week 12. |
A synthetic PCSK9 peptide-based immunotherapy |
|
실험적: VXX-401 Cohort F
VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 300 mcg administered by intramuscular (IM) injection at Week 4 and Week 12. |
A synthetic PCSK9 peptide-based immunotherapy |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Frequency of adverse events
기간: 30 weeks
|
Safety and tolerability: rates of adverse events (AEs), medically attended adverse events (MAAEs), local (injection site) and systemic (generalized) reactions (i.e., reactogenicity), clinical laboratory assessments (e.g., chemistry, hematology, urinalysis, lipid profile), serum cytokine release, vital signs, physical examinations, and electrocardiograms (ECGs) through the end of the study. |
30 weeks
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Immunogenicity
기간: Baseline to Week 16, 20, 24, and 30
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Immunogenicity will be measured by serum anti-PCSK9 antibody titers |
Baseline to Week 16, 20, 24, and 30
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Immunogenicity
기간: Baseline to Week 16, 20, 24, and 30
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Seroconversion two-fold and four-fold from baseline |
Baseline to Week 16, 20, 24, and 30
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Determine optimal VXX-401 dose regimen
기간: Baseline to Week 16, 20, 24, and 30
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Measured by serum anti-PCSK9 antibody titers |
Baseline to Week 16, 20, 24, and 30
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of low-density lipoprotein-cholesterol (LDL-C) reduction
기간: Baseline to Week 16, 20, 24, and 30
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Percent change from baseline in serum LDL-C concentration |
Baseline to Week 16, 20, 24, and 30
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 책임자: Sasha Rumyantsev, Vaxxinity, Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- VXX-401-101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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