| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | | Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003. | Posted | | Number | | Participants | | Baseline up to 39 Weeks and at Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG005 | Placebo | Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26 |
| | | Title | Denominators | Categories |
|---|
| Participants with Adverse Events (AEs) | | |
| |
| Primary | Number of Participants With Laboratory Abnormalities | | Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). | Posted | | Number | | Participants | | Baseline up to 39 Weeks and at Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Number of Participants With Vital Signs of Potential Clinical Concern | Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported. | Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). | Posted | | Number | | Participants | | Baseline up to 39 Weeks and at Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
|
| Primary | Number of Participants With Abnormal Physical Examination Findings | | Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid. | Posted | | Number | | Participants | | Baseline up to 39 Weeks and at Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
|
| Primary | Number of Participants With Abnormal Neurological Examination Findings | The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. | Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). n = number of evaluable participants at the corresponding time point. | Posted | | Number | | Participants | | Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 |
|
| Primary | Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1 | | Pharmacokinetic (PK) Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment. | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Average Concentration (Cavg) for AAB-003 in Serum at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Average Concentration (Cavg) for AAB-003 in Serum at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1 | | PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment. | Posted | | Median | Full Range | Hours (hr) | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 | AAB-003 8 mg/kg |
|
| Primary | Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Median | Full Range | Hours (hr) | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1 | | PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | |
|
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | |
|
| Primary | Systemic Clearance (CL) for AAB-003 in Serum at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter/hour/kilogram (mL/hr/kg) | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Systemic Clearance (CL) for AAB-003 in Serum at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/kg | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/kg | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 |
|
| Primary | Serum Decay Half-Life (t1/2) for AAB-003 at Day 1 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Mean | Standard Deviation | Days | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 | AAB-003 8 mg/kg |
|
| Primary | Serum Decay Half-Life (t1/2) for AAB-003 at Week 26 | | Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment). | Posted | | Mean | Standard Deviation | Days | | Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG004 | AAB-003 8 mg/kg |
|
| Primary | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). | Safety Analysis Set included all participants who received at least one infusion of study medication (including partial infusions). | Posted | | Number | | Participants | | Baseline up to Week 39 or Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
|
| Primary | Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding | Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately. | Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions). | Posted | | Number | | Participants | | Baseline up to Week 32. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | |
|
| Primary | Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit | VE of the brain, identified via MRI, was identified as an adverse event of special circumstance. | Safety Analysis Set included all participants who received an infusion of study medication, including partial infusions. n = number of evaluable participants at the corresponding timeframe. | Posted | | Number | | Participants | | Day 1, Week 13, and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
|
| Primary | Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria | Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec. | Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions). | Posted | | Number | | Participants | | Baseline, Weeks 1,13,16,26,39 or Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 |
|
| Other Pre-specified | Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum | Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method | All participants who received an infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Number | | Participants | | Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
|
| Other Pre-specified | Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39 | The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment. | All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 13, 26 and 39 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 |
|
| Other Pre-specified | Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39 | The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning). | All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 13, 26 and 39 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg |
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| Other Pre-specified | Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39 | The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI - delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology). | All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 13, 26 and 39 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg |
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| Other Pre-specified | Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39 | The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories - memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia. | All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 26 and 39 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39 | The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible. | All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 13, 26 and 39 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 |
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| Other Pre-specified | Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32 | Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF. | All randomized and treated participants in the 2, 4 and 8 mg/kg cohorts who consented to the collection of CSF samples. | Posted | | Mean | Standard Deviation | nanogram/millliter (ng/mL) | | Week 32 or Early Withdrawal | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | picogram/milliliter (pg/mL) | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | Placebo | Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | picogram/milliliter (pg/mL) | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | Placebo | Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | Placebo | Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 8 mg/kg | Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | Placebo | Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups | | The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline and Week 32 | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication and have at least one postdose pharmacodynamic (PD) parameter assessment. n = number of evaluable participants at the corresponding timeframe. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe. | Posted | | Median | Full Range | Hours | | Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUClast. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUCinf. No participants had available data for AUCinf in AAB-003 8 mg/kg and Placebo Groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg |
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| Other Pre-specified | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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| Other Pre-specified | Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40 | | All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for t1/2. No participants had available data for t1/2 in AAB-003 8 mg/kg and Placebo Groups. | Posted | | Mean | Standard Deviation | Day | | Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39. | | | | ID | Title | Description |
|---|
| OG000 | AAB-003 0.5 mg/kg | Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG001 | AAB-003 1 mg/kg | Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG002 | AAB-003 2 mg/kg | Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26 | | OG003 | AAB-003 4 mg/kg | Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26 |
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