Amyloidosis; SystemicPhase 1AT03-001NCT05201911
A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis
A Phase 1 study testing 124I-AT03 in people with Amyloidosis; Systemic, run by Attralus, Inc. at 1 site in United States.
Trial summary
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis; Systemic
- What is being tested?
- 124I-AT03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 6 Sep 2022
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands the study procedures and capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female ≥18 years of age.
- Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of systemic amyloidosis based on any one of the following:
- a histologic confirmation with a biopsy containing deposits of apple-green birefringent, congophilic material;
- genetic screening with presence of amyloid-related pathology; and/or
- amyloid-specific imaging study.
Show all 14Show fewer
- Has known involvement of at least one thoracoabdominal organ (excluding peripheral nervous system) by clinical history (e.g., imaging consistent with amyloid deposition, organ biopsy, elevated amyloid-related biomarkers, etc.).
- For women of childbearing potential: agreement to remain as abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study intervention.
- A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
- Contraception methods that do not result in a failure rate of <1% per year such as cap, diaphragm, or sponge with spermicide, or male or female condom with or without spermicide, are not acceptable.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 30 days plus 90 days (a spermatogenesis cycle) after the last dose of study intervention. Men must refrain from donating sperm during this same time period.
Who cannot join
- Is pregnant or breast-feeding.
- Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
- Has participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the 4 months prior to Screening.
- Has a significant co-morbidity (e.g., ECOG score of 3 or greater), NYHA Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
- Has a known allergy to iOSAT iodine treatment.
- Has end-stage renal disease and is receiving hemodialysis or peritoneal dialysis.
- Has received an investigational agent within five half-lives of the agent or 30 days, whichever is longer, prior to Screening.
- Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
Official title: A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select Organs in Patients With Systemic Amyloidosis
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
Read the detailed description
Eligible subjects will receive a single dose of radiolabeled AT-03, a fusion protein of serum amyloid P and a single chain Fc receptor. Repeat Positron Emission Tomography/Computed Tomography (PET/CT) scans will be performed over a ~7 day period to assess the biodistribution of AT-03 to amyloid-containing tissues in patients with systemic amyloidosis.
- Conditions
- Amyloidosis; Systemic
- Being tested
- 124I-AT03
- Keywords
- Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), Leukocyte chemotactic factor 2 amyloidosis (ALECT2), All other forms of systemic amyloidosis
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloidosis, Hereditary, Transthyretin-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-AT03Drug
IV injection of the radiolabeled compound on day 1 followed by Positron Emission Tomography/Computed Tomography (PET/CT) scanning on Days 2, 4 and 8 to. The first 3 subjects enrolled will have two additional scans on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Injection of I-124 AT03. | Experimental | Single arm only, no placebo or comparator Receives: Drug: 124I-AT03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
Measured: Day 4.
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
Measured: Day 6.
Secondary outcomes (4)
Number of participants with treatment-related adverse events.
Incidence of treatment-emergent adverse events from Day 1 to Day 28.
Measured: Assessed from time of consent through the day 28 follow-up phone call.
Number of participants with abnormal laboratory test results.
Change from Baseline in clinical laboratory values at Days 4 and 6.
Measured: Assessed from time of consent through Day 6.
Whole blood radioactivity of 124I-AT-03 in subjects with systemic amyloidosis.
Whole body radiation dose by dosimetry in all enrolled subjects. Whole blood radioactivity (corrected for radioactive decay).
Measured: Days 1, 4, and 6.
Selected tissue-bound half-life of 124I-AT-03 in subjects with systemic amyloidosis.
Organ specific radioactivity for the heart, kidneys, liver, and spleen at Days 4 and 6.
Measured: Days 4 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start30 Nov 2021
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis; SystemicStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attralus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Bell, MD, Study director, Attralus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201911
- Sponsor's protocol ID
- AT03-001
- Acronym
- AT03-001
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2021
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select Organs in Patients With Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT05201911
- Acronym / sponsor ID
- AT03-001 / AT03-001
- Conditions
- Amyloidosis; Systemic
- Keywords
- Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), Leukocyte chemotactic factor 2 amyloidosis (ALECT2), All other forms of systemic amyloidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Attralus, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 21 Jan 2022 (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.
This is a single center Phase 1 study is to evaluate the biodistribution of radiolabeled AT-03 in patients with systemic amyloidosis.
Detailed description
Eligible subjects will receive a single dose of radiolabeled AT-03, a fusion protein of serum amyloid P and a single chain Fc receptor. Repeat Positron Emission Tomography/Computed Tomography (PET/CT) scans will be performed over a ~7 day period to assess the biodistribution of AT-03 to amyloid-containing tissues in patients with systemic amyloidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of I-124 AT03. | Experimental | Drug: 124I-AT03Single arm only, no placebo or comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Understands the study procedures and capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female ≥18 years of age.
- Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis (ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of systemic amyloidosis based on any one of the following:
- Has known involvement of at least one thoracoabdominal organ (excluding peripheral nervous system) by clinical history (e.g., imaging consistent with amyloid deposition, organ biopsy, elevated amyloid-related biomarkers, etc.).
- For women of childbearing potential: agreement to remain as abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study intervention.
Key exclusion criteria (8 listed)
- Is pregnant or breast-feeding.
- Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
- Has participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the 4 months prior to Screening.
- Has a significant co-morbidity (e.g., ECOG score of 3 or greater), NYHA Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
- Has a known allergy to iOSAT iodine treatment.
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 |
|---|---|---|
| 124I-AT03IV injection of the radiolabeled compound on day 1 followed by Positron Emission Tomography/Computed Tomography (PET/CT) scanning on Days 2, 4 and 8 to. The first 3 subjects enrolled will have two additional scans on Day 1. | Drug | Injection of I-124 AT03. |
Primary outcome
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Time frame: Day 4.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series.
Time frame: Day 6.
Visual determination of 124I-AT-03 uptake in the heart, kidneys, liver and spleen (positive or negative) at Days 4 and 6.
4 secondary outcomes
Number of participants with treatment-related adverse events.
Time frame: Assessed from time of consent through the day 28 follow-up phone call.
Number of participants with abnormal laboratory test results.
Time frame: Assessed from time of consent through Day 6.
Whole blood radioactivity of 124I-AT-03 in subjects with systemic amyloidosis.
Time frame: Days 1, 4, and 6.
Selected tissue-bound half-life of 124I-AT-03 in subjects with systemic amyloidosis.
Time frame: Days 4 and 6.
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 15 Sep 2022.
- 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.
Gregory Bell, MD study director
Attralus, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 124I-AT03 in people with Amyloidosis; Systemic, run by Attralus, Inc. 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 14 inclusion and 8 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 15 Sep 2022. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To measure the tissue distribution of 124I-AT-03 in select organs in patients with systemic amyloidosis as shown in the Positron Emission Tomography/Computed Tomography (PET/CT scans) series. (time frame: Day 4.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2022.