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NM8074 · 1 trial · 1 indication
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...
NM8074 is an investigational small molecule being studied in healthy adult volunteers. It is currently in Phase 1 clinical development, with a completed first-in-human study evaluating its safety and tolerability. The drug is not approved for any condition and remains in early-stage clinical testing.
NM8074 is being developed by Labcorp Holdings Inc., which trades under the ticker symbol LH. The company is conducting clinical trials for this investigational small molecule, which is currently in Phase 1 development.
NM8074 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing early-stage clinical testing.
NM8074 has one completed clinical trial, NCT05642546, titled "First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers." This Phase 1 study enrolled 40 participants in the United States and was randomized, double-blind, and placebo-controlled.
No, NM8074 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A first-in-human study has been completed, but the drug has not yet received regulatory approval for any use.