A phase 1, placebo-controlled, single ascending-dose study to assess the safety, tolerability and pharmacokinetics of OTL-038 injection in healthy volunteers
- Conditions
- carcinoma10027655cancer
- Registration Number
- NL-OMON40422
- Lead Sponsor
- On Target Laboratories LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
*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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Safety is the primary endpoint of the study and it will be assessed from<br /><br>data on the occurrence of 1 or more treatment-emergent adverse events (TEAEs)<br /><br>from the time of administration throughout the study period, and changes in<br /><br>serum biochemistry, hematology, urinalysis, vital signs, ECG, injection site<br /><br>status, and physical examination findings.</p><br>
- Secondary Outcome Measures
Name Time Method <p>2) Analysis of the PK of OTL-038.</p><br>