NCT07733089招募中1 期
An Interventional, Randomized, Double-blind, Placebo-controlled, Multiple Dose Trial Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Clinical Efficacy of ZP9830 Administered for 8 Weeks in Participants With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this trial is to investigate the effects of repeated administration of ZP9830 for 8 weeks in participants with plaque psoriasis. Here, the primary aim is to evaluate safety and tolerability of ZP9830, the secondary aims are to test clinical efficacy and pharmacokinetics, and lastly the exploratory aim is to test the pharmacodynamic effects of ZP9830 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a confirmed diagnosis of psoriasis (stable plaque psoriasis ≥ 2 months).
- •Participants who have ≥ 2 vulgar psoriatic plaques.
- •BMI within the range 18.0-35.0 kg/m2 (inclusive).
- •Further inclusion criteria apply.
排除标准
- •Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis.
- •Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate).
- •Any clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hematology, biochemistry, and urinalysis).
- •Any clinically significant abnormal findings during the standardized neurological examination conducted at screening.
- •Use of any concurrent systemic medications that could affect psoriasis or psoriasis evaluation, including corticosteroids, retinoids, cyclosporine, methotrexate, PDE4s (phosphodiesterase 4), or biologic agents within 30 days prior to IMP administration or planned to use during the course of the trial.
- •Use of concurrent topical medications containing corticosteroids, retinoids, calcitriol or other topical medication relevant to psoriasis treatment (must be discontinued at least 2 weeks prior to baseline).
- •Use of any biologic or advance systemic therapies for any autoimmune disease within the last 12 months.
- •Use of UVA, PUVA, or UVB therapy and tanning beds within 4 weeks of baseline or during trial participation.
- •Further exclusion criteria apply.
研究组 & 干预措施
ZP9830
Experimental
The experimental arm is divided into two treatment arms with different dose frequencies.
干预措施: ZP9830 (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: From baseline (Day 1, predose) to follow-up (Day 85)
To evaluate the safety and tolerability of ZP9830 following administration of multiple doses in participants with plaque psoriasis.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Evaluation the Efficacy of Zinc on Botulinum Toxin A InjectionNCT07270042Tishreen University20
招募中
1 期
A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and ObesityHealthy Participants StudyOverweight and Obese AdultsFirst in Man Study to Evaluate Initial SafetyNCT07721597Zealand Pharma88
招募中
2 期
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced FibrosisHepatic CirrhosisNCT07610837AstraZeneca104
招募中
2 期
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal AntibodyClostridioides Difficile InfectionNCT07285213AstraZeneca230
招募中
1 期
A trial to learn if AZD9829 is safe and works alone and in combination with other treatments for participants with certain blood cancers.2023-506997-11-00Astrazeneca AB14