cancer carcinoma
Conditions
Interventions
None listed
Sponsors
On Target Laboratories LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety is the primary endpoint of the study and it will be assessed from data on the occurrence of 1 or more treatment-emergent adverse events (TEAEs) from the time of administration throughout the study period, and changes in serum biochemistry, hematology, urinalysis, vital signs, ECG, injection site status, and physical examination findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Analysis of the PK of OTL-038. | — |
Countries
Netherlands
Outcome results
None listed