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The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RN6G | Biological | intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular Adverse Events (AEs) | AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported. | Baseline up to Day 168 |
| Incidence and Severity of Systemic Adverse Events (AEs) | AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported. | Baseline up to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G | AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dedicated Phase 1 | Phoenix | Arizona | 85013 | United States | ||
| Retinal Consultants of AZ |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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From a given cohort, no more than 3 participants received treatment on Day 1, the remaining participants in the respective cohort received treatment at least 24 hours thereafter. All the remaining participants were treated on same day, if required, as per site scheduling.
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| ID | Title | Description |
|---|---|---|
| FG000 | RN6G 0.3 mg/kg | Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. |
| FG001 | RN6G 1 mg/kg | Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Biological | intravenous, single dose with experimental dose. |
|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Maximum Observed Plasma Concentration (Cmax) of RN6G | Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G | Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Volume of Distribution (Vd) of RN6G | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Clearance (CL) of RN6G | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Mean Residence Time (MRT) of RN6G | MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Plasma Terminal Half-life (t1/2) of RN6G | Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) | AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165. | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165 |
| Number of Participants With Anti-Drug Anti-body | Participants tested positive for anti-drug anti-body on at least one or more occasions were reported. | Baseline up to Day 168 |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Insight Diagnostic Imaging Center | Phoenix | Arizona | 85015 | United States |
| Amir Hedayati-Rad, MD | Glendale | California | 91206 | United States |
| United Medical Imaging | Inglewood | California | 90301 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| California Pharmacy and Compounding Center | Newport Beach | California | 92660 | United States |
| Jasper Clinic, Inc. | Kalamazoo | Michigan | 49007 | United States |
| Jonathan Rowe, MD | Kalamazoo | Michigan | 49048 | United States |
| Ronald VanderLugt, MD | Kalamazoo | Michigan | 49048 | United States |
| CEDRA Clinical Research, LLC | San Antonio | Texas | 78217 | United States |
| Village Drive Imaging Center | San Antonio | Texas | 78217 | United States |
| Specialty MRI | San Antonio | Texas | 78229 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78233 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| EZ Pass Rx | Bountiful | Utah | 84010 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Rocky Mountain Eye Care Associates, LC | Salt Lake City | Utah | 84107 | United States |
| Western Neurological Associates | Salt Lake City | Utah | 84124 | United States |
| FG002 | RN6G 3 mg/kg | Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| FG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| FG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| FG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| FG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | RN6G 0.3 mg/kg | Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. |
| BG001 | RN6G 1 mg/kg | Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| BG002 | RN6G 3 mg/kg | Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| BG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| BG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| BG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| BG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence and Severity of Ocular Adverse Events (AEs) | AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported. | Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Number | participants | Baseline up to Day 168 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence and Severity of Systemic Adverse Events (AEs) | AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported. | Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Number | participants | Baseline up to Day 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G | AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported. | Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | microgram*hour/milliliter (mcg*hr/mL) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported. | PK analysis population included all participants who received any amount of the single dose of RN6G. | Posted | Mean | Standard Deviation | mcg*hr/mL | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of RN6G | Participants who received RN6G were reported. | PK analysis population included all participants who received any amount of the single dose of RN6G. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G | Participants who received RN6G were reported. | PK analysis population included all participants who received any amount of the single dose of RN6G. | Posted | Median | Full Range | hours | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Volume of Distribution (Vd) of RN6G | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight. | PK analysis population included all participants who received any amount of the single dose of RN6G. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | mL/kilogram (mL/kg) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Clearance (CL) of RN6G | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight. | PK analysis population included all participants who received any amount of the single dose of RN6G. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | mL/hr/kg | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Mean Residence Time (MRT) of RN6G | MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported. | PK analysis population included all participants who received any amount of the single dose of RN6G. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | days | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Plasma Terminal Half-life (t1/2) of RN6G | Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported. | PK analysis population included all participants who received any amount of the single dose of RN6G. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | days | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X) | Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X) | PD analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Median | Full Range | hours | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X) | AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165. | PD analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Mean | Standard Deviation | nanogram*hr/mL (ng*hr/mL) | Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165 |
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| Secondary | Number of Participants With Anti-Drug Anti-body | Participants tested positive for anti-drug anti-body on at least one or more occasions were reported. | Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo. | Posted | Number | participants | Baseline up to Day 168 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RN6G 0.3 mg/kg | Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1. | 0 | 6 | 4 | 6 | ||
| EG001 | RN6G 1 mg/kg | Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1. | 1 | 6 | 5 | 6 | ||
| EG002 | RN6G 3 mg/kg | Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1. | 0 | 6 | 5 | 6 | ||
| EG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. | 0 | 6 | 4 | 6 | ||
| EG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. | 0 | 6 | 6 | 6 | ||
| EG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. | 0 | 6 | 6 | 6 | ||
| EG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. | 0 | 18 | 15 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid artery stenosis | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract cortical | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pupillary disorder | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Retinal pigment epitheliopathy | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Infusion site haematoma | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood pressure diastolic decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Visual acuity tests abnormal | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Paraesthesia oral | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Skin laceration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
Results for pharmacodynamic parameters [Cmax, Tmax and AUC (0-65d) of A beta(1-X)], are presented as absolute values at specified time points and not as change from baseline as planned.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
| Male |
|
| Mild ocular AEs: right eye |
|
| Mild ocular AEs: left eye |
|
| Mild ocular AEs: both eyes |
|
| Moderate ocular AEs: right eye |
|
| Moderate ocular AEs: left eye |
|
| Moderate ocular AEs: both eyes |
|
| Severe ocular AEs: right eye |
|
| Severe ocular AEs: left eye |
|
| Severe ocular AEs: both eyes |
|
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
| OG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
|
|
| OG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
| OG003 |
| RN6G 10 mg/kg |
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
| OG003 | RN6G 10 mg/kg | Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
|
|
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
|
|
| OG004 |
| RN6G 20 mg/kg |
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
|
|
Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
| OG004 | RN6G 20 mg/kg | Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
|
|
| OG004 |
| RN6G 20 mg/kg |
Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG005 | RN6G 40 mg/kg | Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1. |
| OG006 | Placebo | Single intravenous infusion dose of placebo matched to RN6G on Day 1. |
|
|