AMG 529 First in Human Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiovascular

In brief

A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Key facts

Study ID

NCT03170193

Run by

Amgen

People needed

48

Starts

2017-05-15

Expected to finish

2017-11-17

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
• Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
• Women must be of non-reproductive potential as defined in protocol
• Other inclusion criteria may apply

You may not qualify if…

• 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
• Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
• 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
• Positive pregnancy test at screening or day -1
• Other exclusion criteria may apply

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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