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Also known as Adalimumab
BMO-2 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single Injection of 40mg / 0.8 mL BMO-2 |
| Treatment B | ACTIVE_COMPARATOR | Single Injection of 40mg / 0.8 mL EU-Humira |
| Treatment C | ACTIVE_COMPARATOR | Single Injection of 40mg / 0.8 mL US-Humira |
| Name | Type | Description |
|---|---|---|
| BMO-2 | BIOLOGICAL | Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL). |
| EU-Humira | BIOLOGICAL | Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL) |
| US-Humira | BIOLOGICAL | Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL). |
Inclusion Criteria: * Weight: 60.0-95.0 kg. * Body mass index (BMI) : 19.0-30.0 kg/m2, inclusive * Medical history without major pathology. * Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg. * Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinical...
BMO-2 is an investigational monoclonal antibody developed by Viatris Inc. (ticker VTRS). It is in Phase 1 clinical development. The specific therapeutic indication for BMO-2 has not been publicly disclosed, and the program falls outside the main therapeutic areas typically tracked for this developer.
BMO-2 is developed by Viatris Inc., which trades on the Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program for BMO-2, and the company holds the development rights for this monoclonal antibody asset.
BMO-2 is in Phase 1 clinical development. One Phase 1 trial of BMO-2 has been completed, and no trials of BMO-2 are currently active. The program remains investigational and has not been approved by the FDA for any indication.
BMO-2 has been studied in one completed Phase 1 trial, NCT02472912, titled Adalimumab PK Bioequivalence Study to EU and US Sourced Humira. That trial enrolled 270 healthy adult volunteers in Belgium, used a randomized, double-blind, active-controlled design, and has completed.
Yes, BMO-2 is a monoclonal antibody. It is an investigational biologic in Phase 1 development with Viatris Inc. The completed Phase 1 trial NCT02472912 evaluated pharmacokinetic bioequivalence in 270 healthy volunteers in Belgium under a randomized, double-blind, active-controlled design.