ACTRN12624000086561招募中1 期
A Randomised, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous, Ascending Single and Multiple Doses of AP13 in Healthy Adults
Apollo Therapeutics0 个研究点目标入组 70 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Healthy adult males and females, 18 to 55 years of age (inclusive) at screening.
- •2.Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 30.0 kg/m2, with a body weight 50 to 100 kg at screening.
- •3.Is medically healthy (in the opinion of the PI [or delegate]), as determined by pre-study medical history, and without clinically significant abnormalities including:
- •a.Physical examination without any clinically relevant findings.
- •b.Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after 5 minutes in semi-supine position.
- •c.Heart rate in the range of 40 to 90 bpm after 5 minutes rest in semi-supine position.
- •d.Body temperature (tympanic), between 35.5°C and 37.7°C.
排除标准
- •1.History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease/disorder within the past 3 months, or any acute minor illness (e.g. common cold, influenza, minor infection) within the past 1 month, determined by the PI (or delegate) to be clinically relevant.
- •2.History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study.
- •3.Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •4.Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- •5.Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- •6.Positive drugs of abuse test or alcohol breath test results at the screening visit or on admission to the clinic on Day -1.
- •7.Females who are breastfeeding or planning to breastfeed during the study.
- •8.Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug. Note: use of hormonal contraceptives and the occasional use of paracetamol (up to 2 grams per day) and ibuprofen (up to 1.2 grams per day) is permitted.
- •9.Donation of blood or plasma within 30 days prior to first dose of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug. Donating blood is permitted only 120 days (5 x AP13 t1/2) following the last dose of study drug.
- •10.Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
研究者
相似试验
进行中（未招募）
1 期
ot applicableMetastatic Castrate-refractory Prostate CancerMedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-006314-14-CZCureVac AG200
进行中（未招募）
1 期
ot applicableEUCTR2011-006314-14-DECureVac AG200
进行中（未招募）
1 期
A Phase 2 Study to Assess the Efficacy and Safety of Orally Administered DS107 in a once daily doseof 2g in Haemodialysis Patients with Moderate to Severe Uremic PruritusModerate to Severe Uremic PruritusMedDRA version: 20.0Level: LLTClassification code 10060884Term: Uremic pruritusSystem Organ Class: 100000004858EUCTR2017-004098-15-EEDS Biopharma110
招募中
3 期
Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Ovarian Cancer Following Response to First-line Platinum-based chemotherapyCTRI/2021/08/035759AstraZeneca AB
进行中（未招募）
1 期
ot applicableMetastatic Castrate-refractory Prostate CancerMedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-006314-14-GBCureVac AG204