Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
This is a Phase I/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).
The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients).
The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.
研究概览
地位
条件
详细说明
Part A (Single Ascending Dose, SAD) is a randomized, double-blind, placebo-controlled, single-dose escalation design conducted in healthy participants. It includes two sequential dose cohorts. A total of 16 healthy participants are planned, with 8 participants per cohort (6 receiving HXN6005 and 2 receiving placebo). Participants receive a single subcutaneous injection of HXN6005 or placebo. All participants are followed for safety, PK, PD, and anti-drug antibody (ADA) assessments.
Part B (Multiple Ascending Dose, MAD) is a randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. Part B enrolls 16 patients across two dose cohorts, with 8 patients per cohort (6 receiving HXN6005 and 2 receiving placebo). Patients receive multiple subcutaneous injections of HXN6005 or placebo according to the study schedule.
Part C is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. A total of 35 patients are planned to be randomized into two HXN6005 dose groups and one placebo group, receiving multiple subcutaneous doses according to the study schedule. Regular follow-up visits are conducted to collect efficacy data, safety data, and blood samples for assessment of systemic exposure, immunogenicity, and biomarkers.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名:Tong Gang
- 电话号码:(86)13918569690
- 邮箱:tonggang@helixon.com
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310006
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
-
接触:
- Liming Wu
- 邮箱:18957118053@163.com
-
接触:
- Ying Wang
- 邮箱:nancywangying@163.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
- (Healthy Participants) Male or female participants aged 18 to 55 years (inclusive) at the time of signing the ICF.
- (Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 18.0 and 28.0 kg/m² (inclusive).
- (Patients with AD) Male or female participants aged 18 to 70 years (inclusive) .
- (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening.
Exclusion Criteria:
- Presence of any clinically significant disease at randomization, as judged by the investigator.
- Known or suspected allergy or intolerance to any component or excipient of HXN6005 injection or placebo.
- History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
- Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection.
- History of malignancy or malignant disease, with the exception of surgically excised cutaneous squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ that have been in complete remission for more than 5 years without any evidence of recurrence.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Part A Single Ascending Dose (SAD)
Participants will receive a single subcutaneous dose of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
安慰剂比较:Part A Placebo (SAD)
Participants will receive a single subcutaneous dose of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
|
实验性的:Part B Multiple Ascending Dose (MAD)
Participants will receive multiple subcutaneous doses of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
安慰剂比较:Part B Placebo (MAD)
Participants will receive multiple subcutaneous doses of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
|
实验性的:Part C Multiple Dose efficacy exploration
Participants will receive multiple subcutaneous doses of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
安慰剂比较:Part C Multiple Dose placebo-controlled
Participants will receive multiple subcutaneous doses of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part A Adverse events
大体时间:Up to day 141
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 141
|
|
Part B Adverse Events
大体时间:Up to day 197
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 197
|
|
Part C Efficacy
大体时间:Up to day 113
|
Change from baseline to Week 16 in the Eczema Area and Severity Index (EASI; range 0-72; higher scores indicate more severe disease) total score among AD participants
|
Up to day 113
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
大体时间:Up to day 197
|
The maximum (peak) observed drug concentration in plasma after administration
|
Up to day 197
|
|
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
大体时间:Up to day 197
|
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration
|
Up to day 197
|
|
Incidence of antidrug antibodies (ADA) against HXN6005
大体时间:Up to day 197
|
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
|
Up to day 197
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.