CTRI/2023/10/059183已完成1 期
A Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of topically applied SCD-153 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety by assessing the incidence & severity of AEs, vital signs, clinical laboratory assessments, physical examination & local tolerability assessments
研究概览
简要总结
This is a first-in-human (FIH), randomized,double-blind, vehicle-controlled, sequential cohorts, single ascending doseevaluation of the non-occluded, topical application of SCD-153.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and non-pregnant, non-lactating female volunteers between 18-65 years (both inclusive) of age.
- •2.Voluntarily given informed consent to participate in this study.
- •3.Volunteers must have a 12-lead electrocardiogram (ECG), with no abnormalities considered to be clinically significant, as assessed by the Investigator/Sub-Investigator.
- •4.Clinical laboratory tests are within the normal laboratory reference ranges, or the abnormal values are assessed by the Investigator as clinically not significant.
- •5.The volunteer must be willing and able to comply with study-related instructions and restrictions and willing to remain confined at the clinic for the required duration during the study and to return to the clinic for the follow-up evaluation as specified in this protocol.
排除标准
- •1.Participation in an investigational drug study within 90 days prior to screening.
- •2.Donated blood within 3 months prior to Screening.
- •3.Clinically significant abnormal physical examination findings.
- •4.History of drug and/ or alcohol abuse.
- •5.Has a history of, or any current systemic or dermatologic condition 6.The investigator determines volunteers to have any medical condition that could jeopardize their health or bias the results.
- •7.Volunteers who refuse to refrain from strenuous physical work or exercise from Screening until the end of the study visit.
- •8.Volunteers who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.
结局指标
主要结局
To evaluate the safety by assessing the incidence & severity of AEs, vital signs, clinical laboratory assessments, physical examination & local tolerability assessments
时间窗: upto Day 10
次要结局
- 1. To evaluate the plasma pharmacokinetic parameters - Cmax, Tmax, AUC0-24, AUC0-t, AUC0-inf, t1/2(2. To assess the urinary pharmacokinetic parameters - cumulative amount eliminated in the urine (Ae), a fraction of the dose eliminated in the urine (Fe), & Renal clearance (CLr))
研究者
研究点 (1)
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