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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05642546 | First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers | PHASE1 | COMPLETED | 40 | — | — | Aug 12, 2020 | Jun 15, 2022 | Dec 8, 2022 | 1 | United States |
Adverse events will be graded according to the CTCAE v4.03. If the AE term is not described in the grading scales, the AE severity shall be reported according to the following: * Grade I: Mild (awareness of sign or symptom, but easily tolerated) * Grade II: Moderate (discomfort sufficient to cause interference with normal activities) * Grade III: Severe (incapacitating, with inability to perform normal activities) * Grade IV: Life threatening * Grade V: Fatal
| Arm | Type | Description |
|---|---|---|
| NM8074 | EXPERIMENTAL | 6 subjects per each of the 5 cohorts will receive a single dose of NM8074 administered via IV (intravenous) infusion at 0.3, 1.0, 3.0, 10, or 20 mg/kg |
| Placebo | PLACEBO_COMPARATOR | 2 subjects per each of the 5 cohorts will receive saline placebo administered via IV infusion. |
| Name | Type | Description |
|---|---|---|
| NM8074 | DRUG | Novel, recombinant, humanized monoclonal antibody that selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases |
| Placebo | DRUG | Saline Placebo |
Inclusion Criteria: * Male or Female subjects ≥18 years to ≤60 years of age, inclusive * Body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive and weigh at least 50 kg * QT interval (Fridericia's correction \[QTcF\]); QTcF ≤ 450 msec for males and ≤ 470 msec for females at Screening and pr...