A phase 1a/1b/2a study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer

OnTarget Laboratories0 sites24 target enrollmentJune 25, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 25, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

OnTarget Laboratories

•Healthy volunteers
•1\) Male and 18\-65 years old at screening.
•2\) Able and willing to comply with study procedures, with signed and dated informed consent obtained before any study\-related procedure is performed.
•3\) Agree to use an effective method of contraception for 90 days after administration.
•4\) A body mass index is \=30 kg/m2\.
•5\) The subject is healthy with no acute or chronic medical illnesses, has a normal physical examination, and normal vital signs findings at screening.
•6\) The subject’s screening 12\-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the Investigator
•7\) Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
•8\) Negative test results for drug and alcohol screening.
•9\) Absence of any psychological, familial, sociological or geographical condition that at the

•Healthy volunteers
•1\) Female subjects
•2\) Known acute or chronic disease, abnormal physical examination or blood tests
•3\) The subject has previously been included in an OTL study.
•4\) Use of prescription drugs within 30 days of screening and during study participation
•5\) Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
•6\) History of clinically significant allergies or anaphylactic reactions.
•7\) History of allergy to any of the components of OTL78 or excipients (see Section 3\.2 IB).
•1\) Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
•2\) History of clinically significant allergies or anaphylactic reactions.