Diagnostic Agent Adverse ReactionEarly Phase 1NCT05775601
18F-LY3950321-01 Biodistribution and Safety Study
A Early Phase 1 study testing 18F-LY3950321 and PET Scan in people with Diagnostic Agent Adverse Reaction and Radiation Exposure, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Agent Adverse Reaction, Radiation Exposure
- What is being tested?
- 18F-LY3950321 and PET Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 4 Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- 18F-LY3950321, PET Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-LY3950321Drug
Also called 18F-MNI-1256
3 millicuries (±1 mCi)
PET ScanProcedure or surgery
positron emission tomography (PET) scan
| Study group | Role | What they receive |
|---|---|---|
| 18F-LY3950321 Whole Body Dosimetry | Experimental | Not described Receives: Drug: 18F-LY3950321; Procedure: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: injection to 4 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start28 Feb 2023
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Agent Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avid Medical Director, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775601
- Sponsor's protocol ID
- 18F-LY3950321-01
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15937315International 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.
PubMed 17188183Harrison 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.
PubMed 25816282
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Biodistribution and Safety of 18F-LY3950321 (18F-MNI-1256) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05775601
- Acronym / sponsor ID
- 18F-LY3950321-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-LY3950321 Whole Body Dosimetry | Experimental | Drug: 18F-LY3950321, Procedure: PET Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-LY3950321Also: 18F-MNI-12563 millicuries (±1 mCi) | Drug | 18F-LY3950321 Whole Body Dosimetry |
| PET Scanpositron emission tomography (PET) scan | Procedure or surgery | 18F-LY3950321 Whole Body Dosimetry |
Primary outcome
18F-LY3950321 Whole Body Effective Dose
Time frame: injection to 4 hours postdose
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 15937315Stabin 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.
- Background: PubMed 17188183International 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.
- Background: PubMed 25816282Harrison 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avid Medical Director study director
Avid Radiopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-LY3950321 and PET Scan in people with Diagnostic Agent Adverse Reaction and Radiation Exposure, run by Avid Radiopharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-LY3950321 Whole Body Effective Dose (time frame: injection to 4 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.