임상 레이더 AI | ||
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임상시험 NCT07245368은(는) Mild to Moderate Asthma에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma 1상, 2상 96 무작위 배정 이중 눈가림 위약 대조
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07245368은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Mild to Moderate Asthma에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 11월 4일에 시작되어 96명의 참여자를 모집하고 있습니다. Prana Therapies Inc이(가) 진행하며, 2027년 1월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
Phase 1 of this study will consist of 2 parts
- Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC).
- Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending ...
상세한 설명
This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .
Participants with mild to moderate asthma will b...
더 보기공식 제목
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma
질환명
Mild to Moderate Asthma기타 연구 식별자
- PRA-216-101
NCT 번호
실제 연구 시작일
2025-11-04
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2027-01-31
계획된 등록 인원
96
연구종류
중재연구
단계/상
1상
2상
2상
상태
모집중
키워드
healthy volunteers
pharmacodynamics
immunogenicity
asthma
pharmacokinetics
pharmacodynamics
immunogenicity
asthma
pharmacokinetics
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Phase 1, Part 1: SAD Cohorts: Active Drug Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format. | PRA-216 biologic |
위약 대조군Phase 1, Part 1: SAD Cohorts: Placebo Healthy volunteers will receive a single dose of placebo | 위약 matching placebo for PRA-216 |
실험적Phase 1, Part 2: MAD Cohort: Active Drug Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format. | PRA-216 biologic |
위약 대조군Phase 1, Part 2 MAD Cohort: Placebo Comparator Healthy volunteers will receive repeated doses of placebo comparator. | 위약 matching placebo for PRA-216 |
실험적Phase 2a: Participants with mild to moderate asthma-active drug Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216. | PRA-216 biologic |
위약 대조군Phase 2a: Participants with mild to moderate asthma-placebo Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo. | 위약 matching placebo for PRA-216 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) | Incidence, nature, and severity of serious adverse events (SAEs) | Up to Study Day 169 |
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm) | Incidence, nature, and severity of and serious adverse events (SAEs) | up to Study Day 169 |
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants | Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma. | Up to Study Day 57 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers | Incidence and magnitude of anti-drug antibody following single or multiple doses of PRA-216 | Up to Study Day 169 |
Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers | Time to maximum concentration of drug in plasma following single or multiple doses of PRA-216 | Up to Study Day 169 |
Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers | Area under the curve following single or multiple doses of PRA-216 | Up to Study Day 169 |
Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers | Maximum concentration of PRA-216 in plasma following single or multiple doses of PRA-216. | Up to Study Day 169 |
Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma | Incidence, nature, and severity of serious adverse events (SAEs) | Up to Study Day 197 |
Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma | Incidence and magnitude of anti-drug antibody following drug administration | Up to Study Day 197 |
Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma | Time to maximum concentration of drug in plasma following multiple doses of PRA-216 | Up to Study Day 197 |
Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma | Area under the curve of PRA-216 following multiple doses of PRA-216 | Up to Study Day 197 |
Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma | Maximum concentration in plasma of PRA-216 following multiple doses | Up to Study Day 197 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Age 18-65
- Must be in good health with no significant medical history
- Willing and able to attend all study visits, comply with study requirements
- Able and willing to provide written informed consent
- Evidence of clinically significant condition or disease
- Any physical or psychological condition that prohibits study completion
- Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
- History of severe allergic reactions or hypersensitivity
- Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
Phase 2a
Inclusion criteria:
- Age 18-65
- Must be in good health with no significant medical history
- Willing and able to attend all study visits, comply with study requirements.
- Able and willing to provide written informed consent
- Documented asthma diagnosis prior for at least 12 months prior to screening.
- Symptomatic asthma
- Currently receiving maintenance asthma medications
Exclusion Criteria:
- Evidence of clinically significant condition or disease
- Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
- Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
- History of severe allergic reactions or hypersensitivity
- Current or former smoker with a smoking history of ≥10 pack-years
- Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
- Other investigational agent(s) within 30 days of dosing
Prana Therapies Inc연구 대표 연락처
연락처: Linear site contact, +61 (0)8 6382 5110, [email protected]
7 2개국에 임상시험 장소
New South Wales
Emertitus Research Sydney, Botany, New South Wales, 2019, Australia
Ronald Mak, MD, 연락처, 0289648186, [email protected]
대상자모집전
Victoria
Emeritus Research Camberwell, Camberwell, Victoria, 3124, Australia
Sam Francis, MD, 연락처, 0395096166, [email protected]
대상자모집전
Western Australia
Linear, Joondalup, Western Australia, 6027, Australia
연락처, 011 61 88 6382 5110, [email protected]
대상자모집전
Linear, Nedlands, Western Australia, 6009, Australia
site contact, 연락처, 08 6382 5110, [email protected]
모집중
Auckland
PCRN Waikato, Nawton, Hamilton, Auckland, 3200, New Zealand
Enrollment Coordinator, 연락처, +64 07 960 2123, [email protected]
대상자모집전
Pacific Clinical Research Network-Auckland, Takapuna, Auckland, 0622, New Zealand
Enrollment Coordinator, 연락처, +64 9 242 3321, [email protected]
연락처, [email protected]
대상자모집전
PCRN Wellington, Ebdentown, Upper Hutt, Auckland, 5018, New Zealand
Enrollment Coordinator, 연락처, +64 4 9201800, [email protected]
대상자모집전