18F-LY3950321-01 Biodistribution and Safety Study

A Phase 1, Open-label Study to Evaluate the Biodistribution and Safety of 18F-LY3950321 (18F-MNI-1256) in Healthy Subjects

18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of 18F-LY3950321.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure; Diagnostic Agent Adverse Reaction
• Intervention / Treatment: Procedure: PET Scan; Drug: 18F-LY3950321

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the Imaging Visit.
• Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use contraception and not donate eggs.
• Male subjects with their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male subjects for the study duration and 90 days after study completion.
• Male subjects must not donate sperm for the study duration and for 90 days after study completion.

Exclusion Criteria:

• Current or prior history of any alcohol or drug abuse in the past 2 years.
• Currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening.
• ECG or Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
• Known history of hypersensitivity, including hypersensitivity to the active substances used for 18F-LY3950321 or derivatives, or to any of the associated excipients.
• Subject has received an investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
• Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 milliSieverts, including the procedures in this clinical protocol).
• Pregnant, lactating or breastfeeding.
• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Unsuitable veins for repeated venipuncture.
• Use of any prescription drugs (except approved forms of birth control) or herbal supplements, within 4 weeks prior to Day 1.
• Use of any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to Day 1.
• Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-LY3950321 Whole Body Dosimetry	Procedure: PET Scan; positron emission tomography (PET) scan; Drug: 18F-LY3950321; 3 millicuries (±1 mCi); Other Names: 18F-MNI-1256

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F-LY3950321 Whole Body Effective Dose	Radiation dose estimates. Distribution data will be utilized in the MIRD calculations of target organ radiation absorbed dose with correction from urine assays and standard GI kinetic models in Organ Level Internal Dose Assessment (OLINDA). Standard Medical Internal Radiation Dose (MIRD) assumptions will be incorporated in dosimetry models for determination of radiation absorbed doses in target organs and whole-body.	injection to 4 hours postdose

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals

Publications and helpful links

General Publications

• Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 2005 Jun;46(6):1023-7.
• International Commission on Radiological Protection. Human alimentary tract model for radiological protection. ICRP Publication 100. A report of The International Commission on Radiological Protection. Ann ICRP. 2006;36(1-2):25-327, iii. doi: 10.1016/j.icrp.2006.03.004.
• Harrison J, Lopez PO. Use of effective dose in medicine. Ann ICRP. 2015 Jun;44(1 Suppl):221-8. doi: 10.1177/0146645315576096. Epub 2015 Mar 25.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18F-LY3950321-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No