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SPK-8011QQ · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SPK-8011QQ | EXPERIMENTAL | Participants will receive an intravenous (IV) infusion of SPK-8011QQ on Day 1 of the study. |
| Name | Type | Description |
|---|---|---|
| SPK-8011QQ | DRUG | Participants will receive IV SPK-8011QQ |
Inclusion Criteria: * Signed Informed Consent Form (ICF) * ≥18 years of age at the time of signing the ICF * Male sex assigned at birth * Severe or moderately severe hemophilia A, defined as endogenous FVIII:C activity levels ≤3%, as documented (historically or during the Screening Period) by a cer...
SPK-8011QQ is an investigational gene therapy being studied for the treatment of hemophilia A, specifically in adults with severe or moderately severe forms of the condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
SPK-8011QQ is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The drug is currently in Phase 1 clinical trials for hemophilia A.
SPK-8011QQ is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of hemophilia A. The drug is not yet approved and is currently being evaluated in an early-stage clinical trial to assess its safety and potential efficacy.
SPK-8011QQ is being studied in a Phase 1 clinical trial with the identifier NCT07226206. This trial is titled 'A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A' and is currently recruiting participants in the United States. The trial is an uncontrolled, open-label study with an enrollment target of 5 male participants aged 18 years and older.
SPK-8011QQ is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of hemophilia A. The drug is being studied in a clinical trial to evaluate its safety and potential benefits, but it has not yet received regulatory approval for commercial use.