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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 40 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state. |
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| Cohort 2: 80 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
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| Cohort 3: 120 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
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| Cohort 4: 200 mg ALXN2050/Placebo | Experimental | Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state. |
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| Cohort 5: 120 mg ALXN2050/Placebo | Experimental | Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2050 | Drug | Powder-in-capsule (PIC). |
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| 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 Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050 | Up to 168 hours postdose | |
| Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050 | Up to 168 hours postdose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Auckland | New Zealand |
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| 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 |
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| Cohort 6: 240 mg ALXN2050/Placebo | Experimental | Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state. |
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| Placebo | Drug | PIC. |
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| Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050 | Up to 168 hours postdose |
| Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050 | Up to 72 hours postdose |
| Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050 | Up to 72 hours postdose |
| Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050 | Up to 72 hours postdose |
| Alternative Pathway (AP) Activity As Measured By Wieslab Assay | Up to 14 days postdose |
| Plasma Bb Fragment Of Complement Factor B Concentration Over Time | Up to 14 days 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 |