NL-OMON49366
Completed
Not Applicable
A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer - Study for intraoperative imaging of prostate cancer using OTL78
OnTarget Laboratories0 sites39 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OnTarget Laboratories
- Enrollment
- 39
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers (part A)
- •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 procedures are 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
Exclusion Criteria
- •Healthy volunteers (part A)
- •1\) Female subjects
- •2\) Known acute or chronic disease, abnormal physical examination or blood tests
- •of clinical significance.
- •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.
Outcomes
Primary Outcomes
Not specified
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