Trial Outcomes & Findings for A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (NCT NCT05551741)
NCT ID: NCT05551741
Last Updated: 2026-08-07
Results Overview
Safety Outcome
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
From first dose (Day 1) through end of follow-up visit (Week 48)
Results posted on
2026-08-07
Participant Flow
Participants were enrolled at 10 of 11 study centers across the United Kingdom, Netherlands, and Israel. The first participant was screened on March 02, 2023 and the last participant's last visit was on December 16, 2025.
Of the 75 screened participants, 40 participants were treated after being randomly assigned (3:1) to receive either IBC-Ab002 or matching placebo 4 times in one of the 5 dose level cohorts (Cohorts 1 to 5). IBC-Ab002/placebo was administered IV, with an interval of 12 weeks (once every 12 weeks \[Q12W\]) between doses.
Participant milestones
| Measure |
Cohort #1: IBC-Ab002 Low Dose
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
IBC-Ab002: An anti-PD-L1 monoclonal antibody
|
Cohort #2: IBC-Ab002 Mid Low Dose
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
IBC-Ab002: An anti-PD-L1 monoclonal antibody
|
Cohort #3: IBC-Ab002 Mid Dose
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
IBC-Ab002: An anti-PD-L1 monoclonal antibody
|
Cohort #4: IBC-Ab002 Mid High Dose
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
IBC-Ab002: An anti-PD-L1 monoclonal antibody
|
Cohort #5: IBC-Ab002 High Dose
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
IBC-Ab002: An anti-PD-L1 monoclonal antibody
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
6
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)
Baseline characteristics by cohort
| Measure |
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 8.0 • n=20 Participants
|
70.2 years
STANDARD_DEVIATION 5.0 • n=20 Participants
|
69.3 years
STANDARD_DEVIATION 7.9 • n=40 Participants
|
71.5 years
STANDARD_DEVIATION 7.0 • n=6 Participants
|
70.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 9.1 • n=13 Participants
|
69.1 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=13 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=13 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=4 Participants
|
|
Weight
|
61.25 kg
STANDARD_DEVIATION 6.37 • n=20 Participants
|
72.65 kg
STANDARD_DEVIATION 17.57 • n=20 Participants
|
80.64 kg
STANDARD_DEVIATION 19.62 • n=40 Participants
|
66.33 kg
STANDARD_DEVIATION 5.18 • n=6 Participants
|
74.92 kg
STANDARD_DEVIATION 15.34 • n=7 Participants
|
65.91 kg
STANDARD_DEVIATION 12.68 • n=13 Participants
|
69.57 kg
STANDARD_DEVIATION 14.05 • n=4 Participants
|
|
Body Mass Index (BMI)
|
22.44 kg/m^2
STANDARD_DEVIATION 1.27 • n=20 Participants
|
26.06 kg/m^2
STANDARD_DEVIATION 5.47 • n=20 Participants
|
31.08 kg/m^2
STANDARD_DEVIATION 8.81 • n=40 Participants
|
22.87 kg/m^2
STANDARD_DEVIATION 2.53 • n=6 Participants
|
26.66 kg/m^2
STANDARD_DEVIATION 5.78 • n=7 Participants
|
23.43 kg/m^2
STANDARD_DEVIATION 5.49 • n=13 Participants
|
25.08 kg/m^2
STANDARD_DEVIATION 5.71 • n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events, Serious Adverse Events
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome - complete blood count, white blood cells, red blood cells, platelets, hematocrit, mean corpuscular hemoglobin (MCH), neutrophiles percent, neutrophiles absolute, lymphocytes percent, lymphocytes absolute, monocytes percent, monocytes absolute, eosinophils percent, eosinophils absolute, basophils percent, basophils absolute, mean platelet volume.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Hematology Parameters
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome - sodium, potassium, calcium, phosphorus, glucose, alanine aminotransferase (ALT), aspartate transaminase (AST), lactate dehydrogenase (LDH), creatine kinase (CK), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), bilirubin, creatine, albumin, total protein, amylase, total cholesterol, triglycerides, thyroid function tests (T3, T4, TSH), coagulation panel International normalized ratio (INR) and partial thromboplastin time (PTT).
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Biochemistry Parameters
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome - protein, nitrates, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, hemoglobin.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Urinalysis Parameters
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety outcome - weight, heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Vital Signs
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome - lacunar infarcts, territorial infarct, macroscopic hemorrhage, deep white matter lesions, cerebral contusion, encephalomalacia, infective lesion, aneurysm or vascular malformation, intraparenchymal tumor, meningioma or arachnoid cyst, inflammation, edema.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Development of New Abnormalities on Brain MRI
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Safety Outcome - measured using Columbia Suicidality Rating Scale. Part 1 of the scale (Suicidal Ideation) is comprised of 5 yes/no questions with "yes" indicating suicidal ideation and "no" indicating no suicidal ideation. Part 2 of the scale (Intensity of Ideation) is comprised of 5 items which should be rated with respect to the most severe type if ideation (with 5 being the most severe intensity and 1 being the least intensity). Part 3 of thee scale (Suicidal Behavior) is comprised of 5 yes/no items with "yes" indicating suicidal behavior and "no" indicating no suicidal behavior. Part 4 of the scale (Actual Attempts) is comprised of 2 items which should be rated with respect to the most severe outcome of the suicide attempt (with the highest score indicating the most severe outcome and 0 indicating no harm).
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 Participants
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Increased Suicidality (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and up to Day 84 post-dosePharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
IBC-Ab002 Levels in Serum (PK Parameters: Cmax)
|
75.6 µg/mL
Standard Deviation 15.7
|
213.1 µg/mL
Standard Deviation 73.2
|
438.3 µg/mL
Standard Deviation 149.6
|
802.5 µg/mL
Standard Deviation 74.3
|
—
|
20.8 µg/mL
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Pre-dose and up to Day 84 post-dosePharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
IBC-Ab002 Levels in Serum (PK Parameters: CL)
|
32.8 ml/h
Standard Deviation 4.4
|
28.3 ml/h
Standard Deviation 3.9
|
26.1 ml/h
Standard Deviation 2.8
|
30.4 ml/h
Standard Deviation 8.3
|
—
|
43.0 ml/h
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Pre-dose and up to Day 84 post-dosePharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
IBC-Ab002 Levels in Serum (PK Parameters: AUC)
|
6575.8 h*µg/mL
Standard Deviation 876.5
|
16594.6 h*µg/mL
Standard Deviation 3030.5
|
38441.7 h*µg/mL
Standard Deviation 4175.4
|
75999.7 h*µg/mL
Standard Deviation 12535.6
|
—
|
1471.6 h*µg/mL
Standard Deviation 293.3
|
SECONDARY outcome
Timeframe: Pre-dose and up to Day 84 post-dosePharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
IBC-Ab002 Levels in Serum (PK Parameters: Vd)
|
4164.9 ml
Standard Deviation 365.3
|
3789.4 ml
Standard Deviation 649.7
|
3973.1 ml
Standard Deviation 607.6
|
4272.7 ml
Standard Deviation 758.6
|
—
|
4299.7 ml
Standard Deviation 668.3
|
SECONDARY outcome
Timeframe: From first dose (Day 1) through end of follow-up visit (Week 48)Serological Outcome - Number of participants with positive serum anti-IBC-Ab002 antibodies (ADA), summarized by arm.
Outcome measures
| Measure |
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 Participants
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 Participants
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 Participants
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 Participants
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
Cohort #1: IBC-Ab002 Low Dose
n=6 Participants
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Positive Serum Anti-IBC-Ab002 Antibodies (ADA)
|
5 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
—
|
3 Participants
|
Adverse Events
Cohort #1: IBC-Ab002 Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort #2: IBC-Ab002 Mid Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort #3: IBC-Ab002 Mid Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort #4: IBC-Ab002 Mid High Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort #5: IBC-Ab002 High Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort #1: IBC-Ab002 Low Dose
n=6 participants at risk
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 participants at risk
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 participants at risk
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 participants at risk
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 participants at risk
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 participants at risk
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Cohort #1: IBC-Ab002 Low Dose
n=6 participants at risk
Participants received IBC-Ab002 1 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #2: IBC-Ab002 Mid Low Dose
n=6 participants at risk
Participants received IBC-Ab002 3 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #3: IBC-Ab002 Mid Dose
n=6 participants at risk
Participants received IBC-Ab002 6 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #4: IBC-Ab002 Mid High Dose
n=6 participants at risk
Participants received IBC-Ab002 15 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Cohort #5: IBC-Ab002 High Dose
n=6 participants at risk
Participants received IBC-Ab002 30 mg/kg - Single dose (Part A) and then 3 doses Q12W (Part B)
|
Pooled Placebo
n=10 participants at risk
Participants received Placebo - Single dose (Part A) and then 3 doses Q12W (Part B)
Placebo: Normal Saline
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
50.0%
3/6 • Number of events 4 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
10.0%
1/10 • Number of events 2 • 48 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
16.7%
1/6 • Number of events 4 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
33.3%
2/6 • Number of events 5 • 48 weeks
|
33.3%
2/6 • Number of events 5 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Investigations
Amylase Increased
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 3 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
10.0%
1/10 • Number of events 2 • 48 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
General disorders
Infusion Site Bruising
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
General disorders
Infusion Site Pain
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Covid-19
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 2 • 48 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 2 • 48 weeks
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
50.0%
3/6 • Number of events 3 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 2 • 48 weeks
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 2 • 48 weeks
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Investigations
Tri-Iodothyronine Free Decreased
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 2 • 48 weeks
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 3 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 2 • 48 weeks
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
Behaviour Disorder
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
20.0%
2/10 • Number of events 2 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Surgical and medical procedures
Tooth Restoration
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
10.0%
1/10 • Number of events 1 • 48 weeks
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 4 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 1 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
16.7%
1/6 • Number of events 2 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
|
Eye disorders
Eye Pain
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
33.3%
2/6 • Number of events 2 • 48 weeks
|
0.00%
0/6 • 48 weeks
|
0.00%
0/10 • 48 weeks
|
Additional Information
Tommaso Croese, MD-PhD - VP of Clinical Development & Senior Medical Director
ImmunoBrain Checkpoint, Inc.
Phone: +1-212-758-9760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place