A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Ascletis Recruiting
- 전화번호: +1 2068073688
- 이메일: clinicaltrials@ascletis.com
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21201
- 모병
- Ascletis Clinical Site
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연락하다:
- Ascletis Recruiting
- 이메일: clinicaltrials@ascletis.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
- Are between 18 and 65 years of age (both inclusive) at time of screening.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion Criteria:
- Have evidence of any clinically significant active or chronic disease.
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Have a known clinically significant gastric emptying abnormality.
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SAD Cohort 1
SAD Dose 1 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: SAD Cohort 2
SAD Dose 2 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: SAD Cohort 3
SAD Dose 3 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: SAD Cohort 4
SAD Dose 4 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
활성 비교기: MAD Cohort 0
MAD Cohort 0 |
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection |
|
실험적: MAD Cohort 1
MAD Cohort 1 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: MAD Cohort 2
MAD Cohort 2 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: MAD Cohort 3
MAD Cohort 3 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
|
실험적: MAD Cohort 4
MAD Cohort 4 |
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection. ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse events
기간: Baseline and Day 141
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A summary of AEs, SAEs and other non-serious adverse events |
Baseline and Day 141
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cmax of ASC35
기간: Baseline and Day 141
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Evaluate the peak plasma concentration of ASC35 |
Baseline and Day 141
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Tmax of ASC35
기간: Baseline and Day 141
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Evaluate the time to reach peak plasma concentration of ASC35 |
Baseline and Day 141
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AUC of ASC35
기간: Baseline and Day 141
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Evaluate the area under the plasma concentration-time curve of ASC35 |
Baseline and Day 141
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Change From Baseline in Body Weight
기간: Baseline and Day 141
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Percentage Change From Baseline in Body Weight |
Baseline and Day 141
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Change From Baseline in Body Weight
기간: Baseline and Day 141
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Actual Change From Baseline in Body Weight |
Baseline and Day 141
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공동 작업자 및 조사자
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ASC35-101
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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