A phase 1, placebo-controlled, single ascending-dose study to assess the safety, tolerability and pharmacokinetics of OTL-038 injection in healthy volunteers - Study for safety, tolerability and PK of OTL-038

On Target Laboratories LLC0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•*The subject is 18-65 years old at screening.
•*The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
•*Female subjects need to be either surgically sterile, post menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of OTL-038. Pre-menopausal female subjects should also employ an effective method of birth control for at least one month when it consists of a hormonal contraceptive method or IUD. For non-hormonal contraceptive methods females have to agree to use a double-barrier method.
•*The subject*s body mass index is <=30 kg/m2.
•*The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening (within 21 days before administration of study drug).
•*The subject*s screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
•*The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
•*The subject has negative test results for drug and alcohol screening.
•*The subject has Fitzpatrick skin type I-II-III-IV

•The female subject is lactating or pregnant.
•The subject has been previously included in this study.
•The subjects uses prescription drugs
•The subjects uses OTC-drugs that may have an impact on the study objectives.
•Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
•*History of anaphylactic reactions.
•*History of allergy to any of the components of OTL-038 or clemastine

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