Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12617001521314 | Other Identifier | Australian New Zealand Clinical Trials Registry | |
| U1111-1203-1371 | Other Identifier | Universal Trial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
Not provided
Not provided
Not provided
This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 40 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo on Day 1. |
|
| Cohort 2: 80 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo on Day 1. |
|
| Cohort 3: 120 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2050 | Drug | Powder-in-capsule (PIC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants Experiencing Serious Adverse Events | Day 1 through Day 42 | |
| Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs) | Day 1 through Day 42 | |
| Number Of Participants Experiencing AEs Leading To Discontinuation From The Study | Day 1 through Day 42 | |
| Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities | Day 1 through Day 42 | |
| Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities | Day 1 through Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) Of ALXN2050 | Up to 144 hours postdose | |
| Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050 | Up to 144 hours postdose | |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Auckland | New Zealand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020742 | rhoA GTP-Binding Protein |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | PIC. |
|
| Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050 |
| Up to 144 hours postdose |
| Alternative Pathway (AP) Activity As Measured By Wieslab Assay | Up to 144 hours postdose |
| Plasma Bb Fragment Of Complement Factor B Concentration Over Time | Up to 144 hours postdose |
| 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 |