Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01894165 | Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2013 | Sep 1, 2013 | Mar 19, 2019 | 1 | United States |
Physical examination, vital signs, ECGs, laboratory evaluations, and Adverse Events.
| Arm | Type | Description |
|---|---|---|
| ALXN1101 | EXPERIMENTAL | Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV. |
| Placebo | PLACEBO_COMPARATOR | Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV. |
| Name | Type | Description |
|---|---|---|
| ALXN1101 | DRUG | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
| Placebo | DRUG | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
Key Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg 2. Willing and able to give written informed consent 3. Female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive ...