Trials / Recruiting
RecruitingNCT07422285
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this trial is to evaluate the pharmacokinetics of two evolocumab drug products in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Evolocumab Drug Substance A | Evolocumab drug substance A will be administered SC. |
| DRUG | Evolocumab Drug Substance B | Evolocumab drug substance B will be administered SC. |
Timeline
- Start date
- 2026-01-16
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2026-02-20
- Last updated
- 2026-04-16
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07422285. Inclusion in this directory is not an endorsement.