AMG 529 First in Human Study

Amgen

Status and phase: Completed; Phase 1

Conditions: Cardiovascular

Treatments: Drug: AMG 529; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03170193

20160338

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

AMG 529

Experimental group

Description:

Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.

Treatment:

Drug: AMG 529

Placebo

Placebo Comparator group

Description:

Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.

Treatment:

Drug: Placebo