AmyloidosisPhase 2AT01-001NCT05235269
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
A Phase 2 study testing 124I-AT-01 in people with Amyloidosis, run by Attralus, Inc. at 3 sites in United States.
Trial summary
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- 124I-AT-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2021to 24 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 is 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.
- For women of childbearing potential: agreement to remain abstinent 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 124I-AT-01.
- A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state, and has not undergone surgical sterilization.
- 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.
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- 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.
- 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 120 days (a spermatogenesis cycle) after the last dose of study intervention. Men must refrain from donating sperm during this same time period.
- Able to undergo two PET/CT scans as part of the study, including ability to lie supine for up to 1 hour.
- Has a history of AL or ATTR systemic amyloidosis with at least one organ with clinically demonstrable amyloid involvement defined by:
- AL systemic amyloidosis: Positive tissue biopsy for AL amyloid, and achieved a hematologic very good partial response or complete response based on their most recent assessment, and at least one of the following: 1) Organ biopsy positive for amyloid, or 2) Natriuretic peptide (NT-proBNP) >650 pg/mL, or 3) left ventricle septal wall thickness >12 mm by echocardiogram or cardiac magnetic resonance (CMR), or 4) 24-hour urine protein >500 mg, or 5) Urine albumin-to-creatinine ratio >300 mg/g
- ATTR (wild type or variant) systemic amyloidosis: Positive cardiac biopsy for ATTR amyloid, or at least two of the following: 1) Positive extracardiac tissue biopsy for ATTR amyloid or positive transthyretin gene mutation associated with amyloid, or 2) left ventricle septal wall thickness >12 mm by echocardiogram or CMR, or 3) pyrophosphate (PYP) scintigraphy with myocardial uptake ≥grade 2.
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 received in the last 6 months or are currently receiving treatment with anti-amyloid monoclonal antibody therapy or are expected to begin treatment prior to completing this study.
- Has received heparin or heparin analogs within 7 days of Day 1.
- Has a significant co-morbidity (e.g., Easter Cooperative Oncology Group (ECOG) score of 3 or greater), New York Heart Association (NYHA) Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
- Has active thyroid disease.
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- Has a known allergy to potassium iodine treatment.
- Is receiving hemodialysis or peritoneal dialysis.
- Has severe claustrophobia that would prevent completion of the PET/CT imaging protocol.
- 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
3 sites in 1 country.
United States3 sites
PET/CT Imaging of Berkeley
Berkeley, California, 94705
Northern California PET Imaging Center
Sacramento, California, 95816
PET/CT Imaging of San Jose
San Jose, California, 95128
About this study
Official title: A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.
Read the detailed description
This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01.
- Conditions
- Amyloidosis
- Being tested
- 124I-AT-01
- Keywords
- Amyloid light chain (AL), Amyloid Transthyretin Systemic Amyloidosis (ATTR)
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-AT-01Drug
Also called AT-01, I124-AT-01
All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | 124I-AT-01 Receives: Drug: 124I-AT-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantitation (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.
wCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Smaller values of wCV represent better agreement. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.
Only images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.
Measured: Day 1 and Week 6
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.
wCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.
Only images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.
Measured: Day 1 and Week 6
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.
ICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.
Reader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.
Measured: Day 1 and Week 6
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.
ICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.
Reader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.
Measured: Day 1 and Week 6
Secondary outcomes (13)
Number of Participants With At Least 1 Treatment-Emergent Adverse Event (TEAE)
TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of treatment. Adverse events (AEs) that occurred after the treatment start date, occurred on the treatment start date with a time that was equal to or after treatment start time, or that had a missing AE start date were categorized as treatment emergent.
Measured: Day 1 through the end of the study (up to 14 weeks)
Clinical Laboratory Values - Chemistry (mmol/L)
Changes from baseline in chemistry clinical laboratory values with units of mmol/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (Umol/L)
Changes from baseline in chemistry clinical laboratory values with units of umol/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (g/L)
Changes from baseline in chemistry clinical laboratory values with units of g/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (IU/L)
Changes from baseline in chemistry clinical laboratory values with units of IU/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Changes from baseline in hematology clinical laboratory values with units of % of WBC count
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Changes from baseline in hematology clinical laboratory values with units of 10^9 cells/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (10^12 Cells/L)
Changes from baseline in hematology clinical laboratory values with units of 10^12 cells/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (g/L)
Change from baseline in hematology clinical laboratory values with units of g/L
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)
Changes from Baseline in hematology clinical laboratory values with units of % of total blood cell count
Measured: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Changes from baseline in blood pressure measurements with units of mmHg
Measured: Day 1 post-administration and Week 6 pre-administration and post-administration
Change From Baseline in Vital Signs - Heart Rate (Beats/Min)
Changes from baseline in heart rate measurements with units of beats/min
Measured: Day 1 post-administration and Week 6 pre-administration and post-administration
Change From Baseline in Anti-Drug Antibodies (ADA)
Changes from baseline in ADA
Measured: Post-dose at Week 6 or Safety Follow-up 2 (28 days after Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start30 Nov 2021
- Primary completion6 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmyloidosisStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, no placebo, no comparator
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attralus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory M. Bell, MD, Study director, Attralus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235269
- Sponsor's protocol ID
- AT01--001
- Acronym
- AT01-001
- Status last verified
- Aug 2025
- First submitted
- 10 Dec 2021
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT05235269
- Acronym / sponsor ID
- AT01-001 / AT01--001
- Conditions
- Amyloidosis
- Keywords
- Amyloid light chain (AL), Amyloid Transthyretin Systemic Amyloidosis (ATTR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Attralus, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.
Detailed description
This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, no placebo, no comparator
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: 124I-AT-01124I-AT-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Understands the study procedures and is 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.
- For women of childbearing potential: agreement to remain abstinent 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 124I-AT-01.
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
- Able to undergo two PET/CT scans as part of the study, including ability to lie supine for up to 1 hour.
Key exclusion criteria (11 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 received in the last 6 months or are currently receiving treatment with anti-amyloid monoclonal antibody therapy or are expected to begin treatment prior to completing this study.
- Has received heparin or heparin analogs within 7 days of Day 1.
- Has a significant co-morbidity (e.g., Easter Cooperative Oncology Group (ECOG) score of 3 or greater), New York Heart Association (NYHA) Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
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-AT-01Also: AT-01, I124-AT-01All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds. | Drug | Single arm |
Primary outcome
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Time frame: Day 1 and Week 6
Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantitation (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed. wCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Smaller values of wCV represent better agreement. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP. Only images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Time frame: Day 1 and Week 6
Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed. wCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP. Only images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Time frame: Day 1 and Week 6
Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed. ICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images. Reader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Time frame: Day 1 and Week 6
Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed. ICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images. Reader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.
13 secondary outcomes
Number of Participants With At Least 1 Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 through the end of the study (up to 14 weeks)
Clinical Laboratory Values - Chemistry (mmol/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (Umol/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (g/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Chemistry (IU/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (10^12 Cells/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (g/L)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)
Time frame: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Time frame: Day 1 post-administration and Week 6 pre-administration and post-administration
Change From Baseline in Vital Signs - Heart Rate (Beats/Min)
Time frame: Day 1 post-administration and Week 6 pre-administration and post-administration
Change From Baseline in Anti-Drug Antibodies (ADA)
Time frame: Post-dose at Week 6 or Safety Follow-up 2 (28 days after Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 M. Bell, MD study director
Attralus, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 124I-AT-01 in people with Amyloidosis, run by Attralus, Inc. at 3 sites 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 13 inclusion and 11 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake (time frame: Day 1 and Week 6). The study lists 4 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 4 Sep 2025.