Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crenezumab Formulation 2 | Experimental | A single dose given as two subcutaneous injections on Day 1 |
|
| Crenezumab Formulation 3 | Experimental | A single dose given as two subcutaneous injections on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crenezumab | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2) | Day 1 through Day 85 or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events | Consent through Day 85 or early termination | |
| Incidence of anti-therapeutic antibodies (ATAs) to crenezumab | From Day 1 (Predose) through Day 85 or early termination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evansville | Indiana | 47710 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Crenezumab |
| Drug |
|
|
| Dallas |
| Texas |
| 75247 |
| United States |
| ID | Term |
|---|---|
| C573372 | crenezumab |
| D020742 | rhoA GTP-Binding Protein |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
Not provided
Not provided