Trial Outcomes & Findings for Exploratory Open Label Study for Development of a Method To Detect Dendritic Cells (NCT NCT05482867)
NCT ID: NCT05482867
Last Updated: 2026-07-08
Results Overview
Change in percentage (%) labeling of PBMCs labeled with ICG, reported as a single measure (mean and standard deviation) for the cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion).
Recruitment status
COMPLETED
Target enrollment
46 participants
Primary outcome timeframe
Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Results posted on
2026-07-08
Participant Flow
One Investigator at one study center in the United States (Collaborative Neuroscience Research, LLC, Long Beach 90806, CA, USA) Study is where all Patients were recruited, screened and if qualified were enrolled and treated according to the protocol.
A total of 51 subjects were planned to be enrolled in the study, including 18 healthy adults (5 in Cohort 1, 10 in Cohort 2, and 3 in Cohort 2a, along with 18 healthy elderly (15 in Cohort 3 and 3 in Cohort 3a), and 15 AD patients (in Cohort 4). Final enrollment for Cohort 3 (15 subjects) and Cohort 4 (10 Subjects) with a total enrollment (N = 46) subjects
Participant milestones
| Measure |
Cohort 1
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N=3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N=3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a planned further 5 healthy elderly adults will receive a 2 mg/min ICG infusion. An additional 10 additional elderly were enrolled after the satellite group (n = 15) total for Cohort 3).
|
Cohort4,
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion were planned pre-enrollment. Only 5 additional Probable AD subjects were enrolled after the satelite group (n = 10) total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
3
|
3
|
15
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
3
|
3
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), received an ICG infusion in NSS of 1 mg/min for 120 minute
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), received an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=3 Participants
Cohort 2A, Three healthy adults, received an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N = 3) If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 Participants
Cohort 3A, Three healthy elderly adults, receives an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N = 3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=15 Participants
Cohort 3, healthy elderly adults, received an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 additional healthy elderly adults received a 2 mg/min ICG infusion (n = 15) total for Cohort 3)
|
Cohort4,
n=10 Participants
Cohort 4, Probable AD patients, received an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10) total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
8 Participants
n=23 Participants
|
|
Age, Continuous
Age
|
37.6 years
STANDARD_DEVIATION 8.29 • n=9 Participants
|
33.9 years
STANDARD_DEVIATION 7.58 • n=27 Participants
|
44 years
STANDARD_DEVIATION 8.89 • n=267 Participants
|
69.3 years
STANDARD_DEVIATION 4.16 • n=265 Participants
|
71.4 years
STANDARD_DEVIATION 3.27 • n=568 Participants
|
72.1 years
STANDARD_DEVIATION 10.42 • n=22 Participants
|
57.8 years
STANDARD_DEVIATION 18.65 • n=23 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
9 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
28 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
18 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
12 Participants
n=568 Participants
|
9 Participants
n=22 Participants
|
38 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
8 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
9 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
23 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=9 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
10 Participants
n=27 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
3 Participants
n=267 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
3 Participants
n=265 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
15 Participants
n=568 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
10 Participants
n=22 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
46 Participants
n=23 Participants • A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study.
|
|
Height
|
172.9 centimeters
STANDARD_DEVIATION 10.31 • n=9 Participants
|
167.1 centimeters
STANDARD_DEVIATION 5.94 • n=27 Participants
|
177.2 centimeters
STANDARD_DEVIATION 9.93 • n=267 Participants
|
159.7 centimeters
STANDARD_DEVIATION 13.41 • n=265 Participants
|
161.3 centimeters
STANDARD_DEVIATION 9.89 • n=568 Participants
|
159.6 centimeters
STANDARD_DEVIATION 7.00 • n=22 Participants
|
164.4 centimeters
STANDARD_DEVIATION 9.98 • n=23 Participants
|
|
Weight
|
79.8 kilograms
STANDARD_DEVIATION 10.8 • n=9 Participants
|
70.1 kilograms
STANDARD_DEVIATION 9.02 • n=27 Participants
|
87.8 kilograms
STANDARD_DEVIATION 18.94 • n=267 Participants
|
64.1 kilograms
STANDARD_DEVIATION 24.32 • n=265 Participants
|
68.9 kilograms
STANDARD_DEVIATION 10.54 • n=568 Participants
|
77.7 kilograms
STANDARD_DEVIATION 23.84 • n=22 Participants
|
73.2 kilograms
STANDARD_DEVIATION 15.91 • n=23 Participants
|
PRIMARY outcome
Timeframe: Dosing (Day 0) through Telephone Follow-up (Day 16)Population: TEAEs are presented as total numbers per Cohort.
TEAE evaluations were reported on all randomized subjects who started infusion of ICG (Day 0) through 1 Week post infusion Telephone follow-up (Day 16) All AEs were followed until resolution. The number of participants may have experienced 1 or more TEAEs per Cohort. Participant numbers include Severity, TEAEs leading to Discontinuations, TEAEs leading to Intervention Discontinuation and severity and TEAEs leading to Death.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=3 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=15 Participants
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
n=10 Participants
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
Any TEAEs
|
3 participants
|
6 participants
|
1 participants
|
3 participants
|
7 participants
|
2 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
Non-Serious TEAEs
|
3 participants
|
6 participants
|
0 participants
|
2 participants
|
7 participants
|
1 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
Mild TEAEs
|
3 participants
|
6 participants
|
1 participants
|
3 participants
|
7 participants
|
2 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
Moderate TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
Severe TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to Study Intervention Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Treatment Emergent Adverse Events (TEAEs)
TEAEs Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening, Day 0 and Day 2Population: All ECG Results per Cohort are listed as Normal, Abnormal Not Clinically Significant (NCS) and Clinically Signiant (CS) at specified time points.
The numbers of participants with overall ECG interpretations by the Investigator as Normal; Abnormal, Not Clinically significant (Abnormal NCS); and Abnormal, Clinically Significant (Abnormal CS) are completed at Screening, On Day 0, 30 minutes post start of ICG infusion and Day 2, 48 hours post start of infusion.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=3 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=15 Participants
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
n=10 Participants
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Electrocardiogram Results
Normal ECGs Screening
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Electrocardiogram Results
Abnormal ECGs NCS at Screening
|
3 participants
|
8 participants
|
3 participants
|
2 participants
|
11 participants
|
9 participants
|
|
Electrocardiogram Results
Abnormal ECGs CS at Screening
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Electrocardiogram Results
30 Minutes Pre ICG Infusion Normal ECG
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
0 participants
|
|
Electrocardiogram Results
30 Minutes Pre ICG Infusion Abnormal NCS ECG
|
3 participants
|
9 participants
|
2 participants
|
1 participants
|
10 participants
|
10 participants
|
|
Electrocardiogram Results
30 Minutes Pre ICG Infusion abnormal CS ECG
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Electrocardiogram Results
30 minutes post infusion Normal ECG Post infusion
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Electrocardiogram Results
30 minutes post infusion Abnormal NCS ECG Post infusion
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Electrocardiogram Results
30 minutes post infusion Abnormal CS ECG
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Electrocardiogram Results
Day 2 (48 hours) Post ICG Normal ECG
|
0 participants
|
4 participants
|
1 participants
|
2 participants
|
7 participants
|
1 participants
|
|
Electrocardiogram Results
Day 2 (48 hours) Post ICG Infusion Abnormal CNS ECG
|
0 participants
|
6 participants
|
2 participants
|
1 participants
|
8 participants
|
9 participants
|
|
Electrocardiogram Results
Day 2 (48 hours) Post ICG Infusion Abnormal CS ECG
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hoursPopulation: For Cohort 2 (10 subjects) at 60 minutes and 120 minutes time points only 9 subjects were analyzed. For Cohort 3 (15 subjects) at 120 mins and 150 mins time points only 14 subjects were analyzed. In Cohort 4 (10 subjects) at 240 mins and 48 hours only 9 subjects were analyzed. At 48 hours Cohorts 2A (3 subjects) and 3A (3 subjects) had no specimens drawn or analyzed specified in the protocol a priori
Mean concentrations of ICG with full ranges.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=15 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=3 Participants
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
n=10 Participants
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Mean ICG Concentrations
Mean ICG Concentrations at 150 mins
|
313.15 ng/mLs
Interval 26.0 to 1060.6
|
647.11 ng/mLs
Interval 50.0 to 1747.3
|
503.42 ng/mLs
Interval 134.5 to 1554.0
|
124.37 ng/mLs
Interval 73.8 to 211.9
|
153.40 ng/mLs
Interval 127.7 to 396.1
|
189.87 ng/mLs
Interval 81.1 to 465.4
|
|
Mean ICG Concentrations
Mean ICG Concentration at 240 mins
|
22.88 ng/mLs
Interval 13.0 to 36.0
|
193.30 ng/mLs
Interval 74.0 to 615.0
|
168.80 ng/mLs
Interval 84.0 to 255.0
|
18.47 ng/mLs
Interval 8.2 to 30.6
|
85.03 ng/mLs
Interval 43.8 to 140.2
|
73.11 ng/mLs
Interval 4.0 to 134.0
|
|
Mean ICG Concentrations
Mean ICG Concentrations at 48 hours
|
3.44 ng/mLs
Interval 3.1 to 4.4
|
7.42 ng/mLs
Interval 4.1 to 11.6
|
13.53 ng/mLs
Interval 10.0 to 24.0
|
—
|
—
|
1.78 ng/mLs
Interval 1.0 to 5.0
|
|
Mean ICG Concentrations
Mean ICG Concentrations at 60 mins
|
2743.76 ng/mLs
Interval 1350.0 to 3932.8
|
3388.33 ng/mLs
Interval 962.0 to 5996.0
|
4377.45 ng/mLs
Interval 1659.9 to 11101.0
|
2591.10 ng/mLs
Interval 1950.9 to 3039.3
|
5032.67 ng/mLs
Interval 3355.2 to 7100.3
|
3181.98 ng/mLs
Interval 406.8 to 4252.8
|
|
Mean ICG Concentrations
Mean ICG Concentrations at 120 mins
|
626.64 ng/mLs
Interval 20.0 to 1087.2
|
1704.42 ng/mLs
Interval 277.0 to 2654.0
|
3549.71 ng/mLs
Interval 1080.0 to 11784.0
|
2070.60 ng/mLs
Interval 1478.0 to 3123.9
|
3691.77 ng/mLs
Interval 3217.4 to 4384.2
|
3231.84 ng/mLs
Interval 2178.9 to 4554.1
|
PRIMARY outcome
Timeframe: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hourPopulation: PK results for Cohorts 2 and 2A the were combined in a Post Hoc for analysis with results between the NSS and D5W infused . PK results for Cohorts 3 and 3A were also combined in a Post Hoc analysis between the NSS and D5W infused .At 48 hours Cohorts 2A (3 subjects) and 3A (3 subjects) had no specimens drawn or analyzed specified in the protocol a priori.
Cohorts 2A (3 subject and 3A (3 subjects) had no PK specimens drawn or analyzed at 48 hours that was specified in the a protocol a priori. Mean concentrations of ICG, measured with full ranges reported for cohorts 1 and 4. Cohorts 2 and 2A were combined and reported as a post-hoc analysis. Cohorts 3 and 3A were combined and reported as a post-hoc analysis.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=13 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=18 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=10 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Mean ICG concentrations at 60 minutes
|
2743.76 ng/mLs
Interval 1350.0 to 3932.8
|
3189.03 ng/mLs
Interval 1350.0 to 3932.8
|
3189.03 ng/mLs
Interval 962.0 to 5996.0
|
3181.98 ng/mLs
Interval 406.8 to 4252.8
|
—
|
—
|
|
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Mean ICG Concentrations at 120 mins
|
626.64 ng/mLs
Interval 20.0 to 1087.2
|
1795.97 ng/mLs
Interval 277.0 to 3123.9
|
3574.78 ng/mLs
Interval 1084.0 to 11784.0
|
3231.84 ng/mLs
Interval 2178.9 to 4554.1
|
—
|
—
|
|
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Mean ICG Concentrations at 150 mins
|
313.15 ng/mLs
Interval 26.0 to 1060.6
|
526.48 ng/mLs
Interval 50.0 to 1747.3
|
459.30 ng/mLs
Interval 122.7 to 1554.0
|
189.87 ng/mLs
Interval 81.1 to 465.4
|
—
|
—
|
|
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Mean ICG Concentrations at 240 minutes
|
22.88 ng/mLs
Interval 13.0 to 36.0
|
152.95 ng/mLs
Interval 8.2 to 615.0
|
153.17 ng/mLs
Interval 43.8 to 255.0
|
73.11 ng/mLs
Interval 4.0 to 134.0
|
—
|
—
|
|
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Mean ICG Concentrations at 48 hours
|
3.44 ng/mLs
Interval 3.1 to 4.4
|
7.42 ng/mLs
Interval 4.1 to 11.6
|
13.53 ng/mLs
Interval 10.0 to 24.0
|
1.78 ng/mLs
Interval 1.0 to 5.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)Population: Cohort 1 has only 4 subjects with results, Cohort 2A has only 2 subjects with results, Cohort 3A has only one subject with a result with no standard deviation and Cohort 4 has 9 subjects with results.
Change in percentage (%) labeling of PBMCs labeled with ICG, reported as a single measure (mean and standard deviation) for the cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion).
Outcome measures
| Measure |
Cohort 1
n=4 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=15 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=2 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=1 Participants
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
n=9 Participants
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG
|
3.300 % of labeled PBMCs
Standard Deviation 1.817
|
8.830 % of labeled PBMCs
Standard Deviation 4.724
|
15.460 % of labeled PBMCs
Standard Deviation 6.822
|
4.415 % of labeled PBMCs
Standard Deviation 6.060
|
16.200 % of labeled PBMCs
Standard Deviation 0
|
18.844 % of labeled PBMCs
Standard Deviation 7.072
|
PRIMARY outcome
Timeframe: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)Population: Cohorts 2 and 2A results were combined in a between the NSS and D5W infused. Cohorts 3 and 3A results also were combined in a Post Hoc analysis between the NSS and D5W infused.
Change in percentage (%) labeling of PBMCs labeled with ICG (Mean and Standard Deviation) reported as a single measure for the specified cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion). Cohorts 2 and 2A results were combined in this post hoc analysis and Cohorts 3 and 3A results were combined in this post hoc analysis.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=12 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=11 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=9 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG (Post Hoc Analysis)
|
3.300 % of labeled PBMCs
Standard Deviation 1.817
|
8.094 % of labeled PBMCs
Standard Deviation 4.955
|
15.527 % of labeled PBMCs
Standard Deviation 6.475
|
18.844 % of labeled PBMCs
Standard Deviation 7.072
|
—
|
—
|
PRIMARY outcome
Timeframe: Percentage change in NIR-L absorbance was measured at 60 mins. 120 mins, 150 mins, 240 mins and 48 hours after the start of the ICG infusion.Population: The mean and standard deviation for the percentage change in NIR-L absorbance at each time point after the start of infusion were calculated for each cohort.
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light (NIR-L) absorbed by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of the ICG infusion.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=15 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
n=3 Participants
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
n=10 Participants
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Near-infrared Spectroscopy (NIRS) Measures
Percentage change in (NIR-L) absorbance at 150 minutes
|
7.240 Percentage change in NIR-L absorbance
Standard Deviation 7.300
|
17.141 Percentage change in NIR-L absorbance
Standard Deviation 4.244
|
20.143 Percentage change in NIR-L absorbance
Standard Deviation 8.887
|
20.800 Percentage change in NIR-L absorbance
Standard Deviation 0
|
15.333 Percentage change in NIR-L absorbance
Standard Deviation 10.561
|
23.794 Percentage change in NIR-L absorbance
Standard Deviation 11.210
|
|
Near-infrared Spectroscopy (NIRS) Measures
Percentage change in (NIR-L) absorbance at 240 minutes
|
10.140 Percentage change in NIR-L absorbance
Standard Deviation 6.736
|
11.501 Percentage change in NIR-L absorbance
Standard Deviation 7.122
|
17.631 Percentage change in NIR-L absorbance
Standard Deviation 10.271
|
21.810 Percentage change in NIR-L absorbance
Standard Deviation 0
|
12.570 Percentage change in NIR-L absorbance
Standard Deviation 11.485
|
21.402 Percentage change in NIR-L absorbance
Standard Deviation 15.676
|
|
Near-infrared Spectroscopy (NIRS) Measures
Percentage change in (NIR-L) absorbance at 48 hours
|
7.440 Percentage change in NIR-L absorbance
Standard Deviation 3.225
|
3.367 Percentage change in NIR-L absorbance
Standard Deviation 5.768
|
8.206 Percentage change in NIR-L absorbance
Standard Deviation 12.446
|
7.465 Percentage change in NIR-L absorbance
Standard Deviation 8.012
|
2.520 Percentage change in NIR-L absorbance
Standard Deviation 14.599
|
6.774 Percentage change in NIR-L absorbance
Standard Deviation 12.339
|
|
Near-infrared Spectroscopy (NIRS) Measures
Percentage change in (NIR-L) absorbance at 60 minutes
|
12.160 Percentage change in NIR-L absorbance
Standard Deviation 6.538
|
19.360 Percentage change in NIR-L absorbance
Standard Deviation 7.105
|
30.422 Percentage change in NIR-L absorbance
Standard Deviation 13.582
|
21.830 Percentage change in NIR-L absorbance
Standard Deviation 0
|
25.677 Percentage change in NIR-L absorbance
Standard Deviation 14.759
|
28.607 Percentage change in NIR-L absorbance
Standard Deviation 14.582
|
|
Near-infrared Spectroscopy (NIRS) Measures
Percentage change in (NIR-L) absorbance at 120 minutes
|
13.480 Percentage change in NIR-L absorbance
Standard Deviation 7.524
|
22.724 Percentage change in NIR-L absorbance
Standard Deviation 5.204
|
33.573 Percentage change in NIR-L absorbance
Standard Deviation 13.977
|
23.420 Percentage change in NIR-L absorbance
Standard Deviation 0
|
29.137 Percentage change in NIR-L absorbance
Standard Deviation 15.618
|
34.021 Percentage change in NIR-L absorbance
Standard Deviation 14.559
|
PRIMARY outcome
Timeframe: Percentage change in NIR-L absorbance was measured at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours after the start of infusionPopulation: The mean and standard deviation percentage change in NIR-L absorbance was calculated for each time point after the start of ICG infusion. Results for Cohorts 2 and 2A and Cohorts 3 and 3A, the NSS and D5W infusion groups, were combined. Cohorts 2 and 2A and Cohorts 3 and 3A results were combined between the two NSS and D5W infused groups.
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light absorbed (NIR-L) by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue. ICG in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared light (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of ICG infusion.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=13 Participants
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 2A
n=18 Participants
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=10 Participants
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort 3
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort4,
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Percentage change in (NIR-L) absorbance at 150 minutes
|
7.240 Percentage change in NIR-L absorbance
Standard Deviation 7.300
|
17.474 Percentage change in NIR-L absorbance
Standard Deviation 4.175
|
19.342 Percentage change in NIR-L absorbance
Standard Deviation 9.031
|
23.794 Percentage change in NIR-L absorbance
Standard Deviation 11.210
|
—
|
—
|
|
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Percentage change in (NIR-L) absorbance at 60 minutes
|
12.160 Percentage change in NIR-L absorbance
Standard Deviation 6.538
|
19.585 Percentage change in NIR-L absorbance
Standard Deviation 6.781
|
29.629 Percentage change in NIR-L absorbance
Standard Deviation 13.449
|
28.607 Percentage change in NIR-L absorbance
Standard Deviation 14.582
|
—
|
—
|
|
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Percentage change in (NIR-L) absorbance at 120 minutes
|
13.480 Percentage change in NIR-L absorbance
Standard Deviation 7.524
|
22.787 Percentage change in NIR-L absorbance
Standard Deviation 4.941
|
32.834 Percentage change in NIR-L absorbance
Standard Deviation 13.873
|
34.021 Percentage change in NIR-L absorbance
Standard Deviation 14.559
|
—
|
—
|
|
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Percentage change in (NIR-L) absorbance at 240 minutes
|
10.140 Percentage change in NIR-L absorbance
Standard Deviation 6.736
|
12.438 Percentage change in NIR-L absorbance
Standard Deviation 7.437
|
16.787 Percentage change in NIR-L absorbance
Standard Deviation 10.303
|
21.402 Percentage change in NIR-L absorbance
Standard Deviation 15.676
|
—
|
—
|
|
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Percentage change in (NIR-L) absorbance at 48 hours
|
7.440 Percentage change in NIR-L absorbance
Standard Deviation 3.225
|
4.050 Percentage change in NIR-L absorbance
Standard Deviation 5.966
|
7.258 Percentage change in NIR-L absorbance
Standard Deviation 12.532
|
6.774 Percentage change in NIR-L absorbance
Standard Deviation 12.339
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3A,
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort4,
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=5 participants at risk
Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes.
|
Cohort 2
n=10 participants at risk
If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.
|
Cohort 3
n=15 participants at risk
Cohort 3, healthy elderly adults, will receive an ICG infusion in NSS of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 more healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).
|
Cohort 2A
n=3 participants at risk
Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly
|
Cohort 3A,
n=3 participants at risk
Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects
|
Cohort4,
n=10 participants at risk
Cohort 4, Probable AD patients, will receive an ICG infusion of D5W of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 5 more AD patients will receive a 2 mg/min ICG infusion (n = 10 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
20.0%
2/10 • Number of events 2 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
20.0%
3/15 • Number of events 3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Nervous system disorders
Dizzyness
|
20.0%
1/5 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
20.0%
3/15 • Number of events 3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
20.0%
2/10 • Number of events 2 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Investigations
Blood Pressure Increase
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
20.0%
3/15 • Number of events 3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Investigations
Blood Bilirubin Increase
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
13.3%
2/15 • Number of events 2 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Renal and urinary disorders
Chromaturia
|
20.0%
1/5 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
26.7%
4/15 • Number of events 4 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
General disorders
Infusion Site Extravastion
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
6.7%
1/15 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
General disorders
Infusion Site Pain
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
6.7%
1/15 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
General disorders
Injection Site Pain
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
6.7%
1/15 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Gastrointestinal disorders
Abnormal Feces
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
20.0%
1/5 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
10.0%
1/10 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Skin and subcutaneous tissue disorders
Skin Irratation
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
33.3%
1/3 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Eye disorders
Vision Blurred
|
20.0%
1/5 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/15 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/5 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
6.7%
1/15 • Number of events 1 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/3 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
0.00%
0/10 • The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
|
Additional Information
Frank S. Menniti, Ph.D., Chief Science Officer
MindImmune Therapeutics, Inc.
Phone: 860 271 9706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place