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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05307978 | Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | Apr 12, 2022 | Feb 7, 2023 | Feb 27, 2025 | 1 | United Kingdom |
The safety and tolerability of ALXN1910 was assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV. |
| Cohort 2 | EXPERIMENTAL | Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. |
| Cohort 3 | EXPERIMENTAL | Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV. |
| Cohort 4 | EXPERIMENTAL | Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. |
| Cohort 5 | EXPERIMENTAL | Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC. |
| Cohort 6 | EXPERIMENTAL | Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC. |
| Name | Type | Description |
|---|---|---|
| ALXN1910 | DRUG | Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. |
| Placebo | DRUG | Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
Inclusion Criteria: * Healthy participants * Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents). * Participants of Japanese descent must be between 20 and 55 years of age. Exclusion Criteria: * Current or recurrent disease * ...