NCT03955666已完成1 期
PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
详细描述
PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.
Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •Body mass index (BMI) 18 to 32 kg/m2, inclusive.
- •Male or female 18 to 50 years of age, inclusive.
- •Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.
排除标准
- •Women who are pregnant or breastfeeding.
- •Evidence of active or chronic infections.
- •Previous exposure to PRV-
- •Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: 85 days
Assessment of safety and tolerability
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) PatientsParoxysmal Nocturnal Hemoglobinuria (PNH)NCT05876312ADARx Pharmaceuticals, Inc.50
已完成
1 期
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19Acute Lung Injury (ALI) Associated With COVID-19Inflammatory Lung Conditions Associated With COVID-19NCT04350736Theravance Biopharma54
已完成
1 期
Recombinant, Bivalent, Norovirus Vaccine StudyNorovirusNCT05508178Icon Genetics GmbH60
已完成
1 期
Phase 1 Study of Epetraborole TabletsHealthy VolunteersNCT04892641AN2 Therapeutics, Inc51
已完成
1 期
Study of SPG302 in Healthy Volunteers and ALS ParticipantsAmyotrophic Lateral SclerosisNCT05882695Spinogenix88