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MEDI 517 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MEDI517 |
| 2 | ACTIVE_COMPARATOR | Aluminum hydroxide |
| Name | Type | Description |
|---|---|---|
| MEDI 517 | BIOLOGICAL | Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant. |
| Aluminum hydroxide | OTHER | Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL. |
Inclusion Criteria: * Female * 18 through 30 years of age (must not have reached the 31st birthday) * Unless previously surgically sterilized, agrees to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combina...
MEDI 517 is an investigational monoclonal antibody developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial involving healthy adult female volunteers who tested positive for HPV-16 or HPV-18 DNA. The trial evaluated the safety and immunogenicity of the MEDI-517P formulation.
MEDI 517 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this monoclonal antibody.
MEDI 517 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
MEDI 517 has been studied in one completed Phase 1 trial, NCT00263744, titled "Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA Positive." The trial enrolled 60 participants and was active-controlled, randomized, and double-blind.
No, MEDI 517 is not FDA approved. It is an investigational monoclonal antibody that has completed a Phase 1 clinical trial and remains in clinical development.