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Also known as Evolocumab Drug Substance A (Test)
Evolocumab Drug Substance A · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Evolocumab Drug Substance A (Test) | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B (Reference) | EXPERIMENTAL | Participants will receive a single SC dose of evolocumab drug substance B. |
| Evolocumab Drug Substance A | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of evolocumab drug substance A. |
| Evolocumab Drug Substance B | EXPERIMENTAL | Participants will receive a single SC dose of evolocumab drug substance B. |
| Name | Type | Description |
|---|---|---|
| Evolocumab Drug Substance A (Test) | DRUG | Evolocumab drug substance A will be administered SC. |
| Evolocumab Drug Substance B (Reference) | DRUG | Evolocumab drug substance B will be administered SC. |
| Evolocumab Drug Substance A | DRUG | Evolocumab drug substance A will be administered SC. |
| Evolocumab Drug Substance B | DRUG | Evolocumab drug substance B will be administered SC. |
Inclusion Criteria: 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m\^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening. Exclu...
Evolocumab Drug Substance A is an investigational small molecule being studied in healthy participants. It is being evaluated in Phase 1 clinical trials to compare how two evolocumab drug products are made available in the body after a single subcutaneous dose. The studies focus on pharmacokinetics in healthy volunteers.
Evolocumab Drug Substance A targets PCSK9, a protein involved in cholesterol regulation, and acts as a PCSK9 inhibitor. By inhibiting PCSK9, the drug may increase the liver's ability to remove LDL cholesterol from the blood, though the current trials are focused on pharmacokinetics in healthy participants.
Evolocumab Drug Substance A is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy participants.
Evolocumab Drug Substance A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are active but not recruiting participants, and they are designed to assess how the drug is absorbed and processed in the body.
Evolocumab Drug Substance A is being studied in two Phase 1 clinical trials: NCT07422285 and NCT07545226. Both trials compare how two evolocumab drug products are made available in the body after a single subcutaneous dose in healthy participants. Each trial enrolls 405 participants in the United States.
Yes, Evolocumab Drug Substance A is also known as Evolocumab Drug Substance A (Test). This alternative name may be used in clinical trial documentation or regulatory filings to distinguish the test product during comparative studies.