A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
2026년 8월 12일 업데이트: Zealand Pharma
A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
- Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
- How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?
In the first Part of the study:
Participants will:
• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
In the second Part of the study:
Participants will:
• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
88
단계
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Regulatory Affairs Department Regulatory Affairs Department, MDRA
- 전화번호: +49213140180
- 이메일: clinicaltrialservices@profil.com
연구 연락처 백업
- 이름: Regulatory Affairs Department Regulatory Affairs Department
- 전화번호: +49213140180
- 이메일: clinicaltrialservices@profil.com
연구 장소
-
-
North Rhine-Westphalia
-
Neuss, North Rhine-Westphalia, 독일, 41460
- 모병
- Profil, Institut für Stoffwechselforschung GmbH
-
연락하다:
- Regulatory Affairs Department Regulatory Affairs Department
- 전화번호: +49213140180
- 이메일: clinicaltrialservices@profil.com
-
연락하다:
- Project Management Project Management
- 전화번호: +49213140180
- 이메일: clinicaltrialservices@profil.com
-
수석 연구원:
- Ulrike Hövelmann, MD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
SAD-Part:
- Male participant
- Age between 18 and 55 years, both inclusive
- Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive
MAD-Part:
- Male participant
- Age between 18 and 60 years, both inclusive
- Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
Exclusion Criteria:
SAD-Part and MAD-Part:
- Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
- Treatment for weight management within 3 months before randomization in this trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
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Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
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위약 비교기: Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
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Participants will receive single or multiple subcutaneous dose administrations of Placebo.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety and Tolerability
기간: Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
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Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
SAD Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Peak Plasma Concentration (Cmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Time to Peak Plasma Concentration (Tmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Terminal rate constant (λz)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Terminal half-life (t½)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
Apparent volume of distribution during terminal phase (Vz/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
기간: SAD-Part: From Day 1 to Day 29
|
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
Trough concentration measured predose for MAD cohorts (Cτ)
|
MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal rate constant (λz)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal half-life (t½)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent volume of distribution during terminal phase (Vz/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
기간: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 7월 9일
기본 완료 (추정된)
기본 완료
2027년 9월 6일
연구 완료 (추정된)
연구 완료
2027년 9월 6일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 16일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 22일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 12일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ZP6590-26033
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .