A Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of topically applied SCD-153 in Healthy Volunteers - Nil

Sun Pharma Advanced Research Company Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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.

•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

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