Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
Recruiting
Phase 1
Interventional Study
Healthy Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 400 (estimated)
- Sponsor
- Amgen · Industry
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About This Trial
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.
Trial Locations
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Eligibility Criteria
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…
Contacts