AMG 529 20160338 First in Human Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 12/7/2017 |
Start Date: | May 15, 2017 |
End Date: | November 24, 2017 |
A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 529 in Healthy Subjects
A study to assess the safety and tolerability of AMG 529 following single, ascending doses
administered subcutaneously (SC) or intravenously (IV) in healthy subjects
administered subcutaneously (SC) or intravenously (IV) in healthy subjects
This is a randomized, double-blind, placebo-controlled, ascending single-dose study in
healthy subjects, which will be conducted at 1 to 3 sites in the United States.
Approximately 48 subjects will enroll in 1 of 6 dose cohorts (8 per cohort).
healthy subjects, which will be conducted at 1 to 3 sites in the United States.
Approximately 48 subjects will enroll in 1 of 6 dose cohorts (8 per cohort).
Inclusion Criteria:
1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically
relevant medical disorders
2. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening
3. Women must be of non-reproductive potential as defined in protocol
4. Other inclusion criteria may apply
Exclusion Criteria:
1. Currently receiving treatment in another investigational device or drug study, or less
than 30 days or 5 half-lives (whichever is longer), since ending treatment on another
investigational device or drug study(s) prior to receiving the first dose of
investigational product
2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through
90 days after receiving the dose of investigational product
3. Men with partners who are pregnant or planning to become pregnant while the subject is
on study through 90 days after receiving the dose of investigational product
4. Positive pregnancy test at screening or day -1
5. Other exclusion criteria may apply
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