AMG 529 First in Human Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2017-11-17

Brief Summary

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

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Detailed Description

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Conditions

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Cardiovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 529

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

Group Type EXPERIMENTAL

AMG 529

Intervention Type DRUG

Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single doses of matching placebo by SC or IV injection

Interventions

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AMG 529

Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection

Intervention Type DRUG

Placebo

Single doses of matching placebo by SC or IV injection

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes