Trial Outcomes & Findings for A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis (NCT NCT05235269)
NCT ID: NCT05235269
Last Updated: 2025-09-04
Results Overview
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.
COMPLETED
PHASE2
33 participants
Day 1 and Week 6
2025-09-04
Participant Flow
Of the initial 34 participants screened, 32 participants met inclusion criteria and were enrolled for treatment. Two participants were screen failures, one of whom was re-screened and subsequently enrolled in the study.
Participant milestones
| Measure |
124I-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.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Day 1
|
33
|
|
Overall Study
Week 6
|
27
|
|
Overall Study
Safety Follow-up 1
|
26
|
|
Overall Study
Safety Follow-up 2 (EOS)
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
124I-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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Participant elected to drop out (i.e., not undergo second scan) but did not withdraw consent
|
1
|
|
Overall Study
Protocol-specified withdrawal criterion met
|
5
|
Baseline Characteristics
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
Baseline characteristics by cohort
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 10.86 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Week 6Population: The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.
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.
Outcome measures
| Measure |
124I-AT-01
n=27 Participants
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.
|
|---|---|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 1
|
14.58 coefficient of variation
Interval -31.4 to 45.8
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 2
|
14.50 coefficient of variation
Interval -31.3 to 45.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 3
|
12.97 coefficient of variation
Interval -28.7 to 40.2
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 1
|
16.28 coefficient of variation
Interval -34.2 to 51.9
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 2
|
9.46 coefficient of variation
Interval -22.2 to 28.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 3
|
15.18 coefficient of variation
Interval -32.4 to 48.0
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 1
|
14.38 coefficient of variation
Interval -31.1 to 45.1
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 2
|
6.54 coefficient of variation
Interval -16.1 to 19.2
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 3
|
7.97 coefficient of variation
Interval -19.1 to 23.7
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 1
|
8.69 coefficient of variation
Interval -20.6 to 26.0
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 2
|
9.64 coefficient of variation
Interval -22.5 to 29.1
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 3
|
8.39 coefficient of variation
Interval -20.1 to 25.0
|
PRIMARY outcome
Timeframe: Day 1 and Week 6Population: The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.
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.
Outcome measures
| Measure |
124I-AT-01
n=27 Participants
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.
|
|---|---|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 1
|
13.06 coefficient of variation
Interval -28.8 to 40.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 2
|
11.57 coefficient of variation
Interval -26.2 to 35.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Reader 3
|
8.21 coefficient of variation
Interval -19.6 to 24.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 1
|
12.82 coefficient of variation
Interval -28.4 to 39.7
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 2
|
9.95 coefficient of variation
Interval -23.1 to 30.1
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Reader 3
|
13.88 coefficient of variation
Interval -30.2 to 43.4
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 1
|
9.68 coefficient of variation
Interval -22.6 to 29.2
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 2
|
8.37 coefficient of variation
Interval -20.0 to 25.0
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Reader 3
|
8.32 coefficient of variation
Interval -19.9 to 24.8
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 1
|
12.47 coefficient of variation
Interval -27.8 to 38.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 2
|
12.48 coefficient of variation
Interval -27.8 to 38.5
|
|
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Reader 3
|
12.84 coefficient of variation
Interval -28.4 to 39.8
|
PRIMARY outcome
Timeframe: Day 1 and Week 6Population: The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.
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.
Outcome measures
| Measure |
124I-AT-01
n=27 Participants
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.
|
|---|---|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Day 1
|
0.903 correlation coefficient
Interval 0.796 to 0.955
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Week 6
|
0.955 correlation coefficient
Interval 0.903 to 0.98
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Day 1
|
0.973 correlation coefficient
Interval 0.94 to 0.988
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Week 6
|
0.964 correlation coefficient
Interval 0.922 to 0.984
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Day 1
|
0.971 correlation coefficient
Interval 0.937 to 0.987
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Week 6
|
0.975 correlation coefficient
Interval 0.946 to 0.989
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Day 1
|
0.991 correlation coefficient
Interval 0.979 to 0.996
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Week 6
|
0.996 correlation coefficient
Interval 0.992 to 0.998
|
PRIMARY outcome
Timeframe: Day 1 and Week 6Population: The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.
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.
Outcome measures
| Measure |
124I-AT-01
n=27 Participants
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.
|
|---|---|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Day 1
|
0.960 correlation coefficient
Interval 0.913 to 0.982
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Heart - Week 6
|
0.987 correlation coefficient
Interval 0.97 to 0.994
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Day 1
|
0.994 correlation coefficient
Interval 0.986 to 0.997
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Kidney - Week 6
|
0.991 correlation coefficient
Interval 0.98 to 0.996
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Day 1
|
0.993 correlation coefficient
Interval 0.984 to 0.997
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Liver - Week 6
|
0.990 correlation coefficient
Interval 0.978 to 0.995
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Day 1
|
0.997 correlation coefficient
Interval 0.992 to 0.998
|
|
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Spleen - Week 6
|
0.999 correlation coefficient
Interval 0.997 to 0.999
|
SECONDARY outcome
Timeframe: Day 1 through the end of the study (up to 14 weeks)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
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.
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Number of Participants With At Least 1 Treatment-Emergent Adverse Event (TEAE)
|
13 Participants
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in chemistry clinical laboratory values with units of mmol/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Calcium - Week 6
|
-0.028 mmol/L
Standard Deviation 0.1079
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Calcium - Safety Follow-up 1
|
-0.035 mmol/L
Standard Deviation 1.1013
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Carbon Dioxide - Week 6
|
-0.7 mmol/L
Standard Deviation 3.06
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Carbon Dioxide - Safety Follow-up 1
|
-1.0 mmol/L
Standard Deviation 2.29
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Chloride - Week 6
|
-0.9 mmol/L
Standard Deviation 2.65
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Chloride - Safety Follow-up 1
|
0.4 mmol/L
Standard Deviation 2.74
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Glucose - Week 6
|
0.3515 mmol/L
Standard Deviation 1.34157
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Glucose - Safety Follow-up 1
|
0.1310 mmol/L
Standard Deviation 1.63653
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Phosphate - Week 6
|
0.0025 mmol/L
Standard Deviation 0.16570
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Phosphate - Safety Follow-up 1
|
0.0229 mmol/L
Standard Deviation 0.16665
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Potassium - Week 6
|
-0.11 mmol/L
Standard Deviation 0.462
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Potassium - Safety Follow-up 1
|
0.4 mmol/L
Standard Deviation 2.74
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Sodium - Week 6
|
-0.2 mmol/L
Standard Deviation 3.32
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Sodium - Safety Follow-up 1
|
0.8 mmol/L
Standard Deviation 2.71
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Urea Nitrogen - Week 6
|
0.2116 mmol/L
Standard Deviation 1.81616
|
|
Clinical Laboratory Values - Chemistry (mmol/L)
Urea Nitrogen - Safety Follow-up 1
|
-0.0429 mmol/L
Standard Deviation 2.17049
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in chemistry clinical laboratory values with units of umol/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Chemistry (Umol/L)
Bilirubin - Week 6
|
1.0136 umol/L
Standard Deviation 4.00446
|
|
Clinical Laboratory Values - Chemistry (Umol/L)
Bilirubin - Safety Follow-up 1
|
1.2315 umol/L
Standard Deviation 2.44487
|
|
Clinical Laboratory Values - Chemistry (Umol/L)
Creatinine - Week 6
|
5.24 umol/L
Standard Deviation 18.541
|
|
Clinical Laboratory Values - Chemistry (Umol/L)
Creatinine - Safety Follow-up 1
|
1.77 umol/L
Standard Deviation 14.430
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in chemistry clinical laboratory values with units of g/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Chemistry (g/L)
Albumin - Week 6
|
-0.4 g/L
Standard Deviation 2.79
|
|
Clinical Laboratory Values - Chemistry (g/L)
Albumin - Safety Follow-up 1
|
-1.5 g/L
Standard Deviation 2.84
|
|
Clinical Laboratory Values - Chemistry (g/L)
Protein - Week 6
|
-0.7 g/L
Standard Deviation 4.22
|
|
Clinical Laboratory Values - Chemistry (g/L)
Protein - Safety Follow-up 1
|
-1.7 g/L
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in chemistry clinical laboratory values with units of IU/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Chemistry (IU/L)
Alanine Aminotransferase - Week 6
|
-1.4 IU/L
Standard Deviation 9.54
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Alanine Aminotransferase - Safety Follow-up 1
|
-2.6 IU/L
Standard Deviation 8.03
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Alkaline Phosphatase - Week 6
|
-2.9 IU/L
Standard Deviation 13.20
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Alkaline Phosphatase - Safety Follow-up 1
|
-3.1 IU/L
Standard Deviation 12.46
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Aspartate Aminotransferase - Week 6
|
-0.3 IU/L
Standard Deviation 6.78
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Aspartate Aminotransferase - Safety Follow-up 1
|
-1.8 IU/L
Standard Deviation 5.64
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Lactate Dehydrogenase - Week 6
|
1.1 IU/L
Standard Deviation 55.16
|
|
Clinical Laboratory Values - Chemistry (IU/L)
Lactate Dehydrogenase - Safety Follow-up 1
|
-6.0 IU/L
Standard Deviation 49.70
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in hematology clinical laboratory values with units of % of WBC count
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Basophils/Leukocytes - Week 6
|
-0.1 % of WBC count
Standard Deviation 0.77
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Basophils/Leukocytes - Safety Follow-up 1
|
-0.1 % of WBC count
Standard Deviation 0.81
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Eosinophils/Leukocytes - Week 6
|
-0.2 % of WBC count
Standard Deviation 1.41
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Eosinophils/Leukocytes - Safety Follow-up 1
|
-0.1 % of WBC count
Standard Deviation 1.72
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Lymphocytes/Leukocytes - Week 6
|
0.0 % of WBC count
Standard Deviation 6.62
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Lymphocytes/Leukocytes - Safety Follow-up 1
|
1.1 % of WBC count
Standard Deviation 6.32
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Monocytes/Leukocytes - Week 6
|
-0.3 % of WBC count
Standard Deviation 4.57
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Monocytes/Leukocytes - Safety Follow-up 1
|
-0.7 % of WBC count
Standard Deviation 4.68
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Neutrophils/Leukocytes - Week 6
|
0.6 % of WBC count
Standard Deviation 9.62
|
|
Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)
Neutrophils/Leukocytes - Safety Follow-up 1
|
-0.1 % of WBC count
Standard Deviation 9.59
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in hematology clinical laboratory values with units of 10\^9 cells/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Leukocytes - Safety Follow-up 1
|
-0.29 10^9 cells/L
Standard Deviation 2.115
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Lymphocytes - Week 6
|
-0.02 10^9 cells/L
Standard Deviation 0.314
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Lymphocytes - Safety Follow-up 1
|
0.02 10^9 cells/L
Standard Deviation 0.287
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Monocytes - Week 6
|
-0.02 10^9 cells/L
Standard Deviation 0.208
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Monocytes - Safety Follow-up 1
|
-0.06 10^9 cells/L
Standard Deviation 0.156
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Neutrophils - Week 6
|
-0.22 10^9 cells/L
Standard Deviation 1.984
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Neutrophils - Safety Follow-up 1
|
-0.21 10^9 cells/L
Standard Deviation 2.028
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Platelets - Week 6
|
4.4 10^9 cells/L
Standard Deviation 35.43
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Platelets - Safety Follow-up 1
|
3.1 10^9 cells/L
Standard Deviation 37.26
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Basophils - Week 6
|
-0.02 10^9 cells/L
Standard Deviation 0.051
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Basophils - Safety Follow-up 1
|
-0.03 10^9 cells/L
Standard Deviation 0.057
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Eosinophils - Week 6
|
-0.02 10^9 cells/L
Standard Deviation 0.085
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Eosinophils - Safety Follow-up 1
|
-0.01 10^9 cells/L
Standard Deviation 0.108
|
|
Clinical Laboratory Values - Hematology (10^9 Cells/L)
Leukocytes - Week 6
|
-0.27 10^9 cells/L
Standard Deviation 1.961
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in hematology clinical laboratory values with units of 10\^12 cells/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Hematology (10^12 Cells/L)
Erythrocytes - Week 6
|
0.000 10^12 cells/L
Standard Deviation 0.2684
|
|
Clinical Laboratory Values - Hematology (10^12 Cells/L)
Erythrocytes - Safety Follow-up 1
|
-0.055 10^12 cells/L
Standard Deviation 0.2600
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Change from baseline in hematology clinical laboratory values with units of g/L
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Hematology (g/L)
Hemoglobin - Week 6
|
-0.4 g/L
Standard Deviation 8.60
|
|
Clinical Laboratory Values - Hematology (g/L)
Hemoglobin - Safety Follow-up 1
|
-2.1 g/L
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from Baseline in hematology clinical laboratory values with units of % of total blood cell count
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)
Hematocrit - Week 6
|
-0.19 % of total blood cell count
Standard Deviation 2.554
|
|
Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)
Hematocrit - Safety Follow-up 1
|
-0.54 % of total blood cell count
Standard Deviation 2.521
|
SECONDARY outcome
Timeframe: Day 1 post-administration and Week 6 pre-administration and post-administrationPopulation: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in blood pressure measurements with units of mmHg
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Systolic Blood Pressure - Day 1 Post-Administration
|
-2.8 mmHg
Standard Deviation 9.21
|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Systolic Blood Pressure - Week 6 Pre-Administration
|
-3.9 mmHg
Standard Deviation 15.97
|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Systolic Blood Pressure - Week 6 Post-Administration
|
-8.5 mmHg
Standard Deviation 16.98
|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Diastolic Blood Pressure - Day 1 Post-Administration
|
-3.2 mmHg
Standard Deviation 6.65
|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Diastolic Blood Pressure - Week 6 Pre-Administration
|
0.2 mmHg
Standard Deviation 11.01
|
|
Change From Baseline in Vital Signs - Blood Pressure (mmHg)
Diastolic Blood Pressure - Week 6 Post-Administration
|
-2.2 mmHg
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Day 1 post-administration and Week 6 pre-administration and post-administrationPopulation: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in heart rate measurements with units of beats/min
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Change From Baseline in Vital Signs - Heart Rate (Beats/Min)
Heart Rate - Day 1 Post-Administration
|
1.1 beats/min
Standard Deviation 7.93
|
|
Change From Baseline in Vital Signs - Heart Rate (Beats/Min)
Heart Rate - Week 6 Pre-Administration
|
0.9 beats/min
Standard Deviation 7.37
|
|
Change From Baseline in Vital Signs - Heart Rate (Beats/Min)
Heart Rate - Week 6 Post-Administration
|
1.0 beats/min
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Post-dose at Week 6 or Safety Follow-up 2 (28 days after Week 6)Population: The Safety Set was defined as all participants who received any amount of 124I-AT-01.
Changes from baseline in ADA
Outcome measures
| Measure |
124I-AT-01
n=33 Participants
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.
|
|---|---|
|
Change From Baseline in Anti-Drug Antibodies (ADA)
Negative for ADA at Screening and negative for ADA post-dose
|
26 Participants
|
|
Change From Baseline in Anti-Drug Antibodies (ADA)
Negative for ADA at Screening and positive for ADA post-dose
|
0 Participants
|
Adverse Events
124I-AT-01
Serious adverse events
| Measure |
124I-AT-01
n=33 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Thalamic infarction
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
Other adverse events
| Measure |
124I-AT-01
n=33 participants at risk
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.
|
|---|---|
|
General disorders
Chest discomfort
|
6.1%
2/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
General disorders
Oedema peripheral
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
General disorders
Vessel puncture site bruised
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Infections and infestations
COVID-19
|
9.1%
3/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Nervous system disorders
Cerebrovascular accident
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Nervous system disorders
Loss of consciousness
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Nervous system disorders
Neuropathy peripheral
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Cardiac disorders
Arrhythmia
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Cardiac disorders
Atrial thrombosis
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Cardiac disorders
Cardiogenic shock
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dysponea
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Endocrine disorders
Hyperparathyroidism
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Investigations
Blood lactic acid increase
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
1/33 • Time of informed consent until the end of the study (up to 14 weeks)
|
Additional Information
Scott Stephens, Senior Director Clinical Operations
Attralus
Results disclosure agreements
- Principal investigator is a sponsor employee All study data will be regarded as confidential until analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented at scientific meetings by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.
- Publication restrictions are in place
Restriction type: OTHER