Back to Search Results
Study Complete
Sponsor ID
20160338

AMG 529 First in Human study

Sponsor ID
20160338
Clinicaltrials.gov ID
NCT03170193
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 529
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
48
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment-emergent adverse events ; safety assessments

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Safety laboratory analytes

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Vital signs

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Electrocardiograms (ECGs)

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Secondary Outcome Measures

PK parameter of maximum observed concentration

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

PK parameter of time of of maximum observed concentration (tmax)

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

PK parameter of area under the concentration time curve (AUC)

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

ALP levels

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Total cholesterol

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

LDL-C

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

HDL-C

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Triglycerides

Timeframe: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days)

Locations

Location
Status
Contact Us
Location
Research Site
Overland Park, KS, United States, 66212
Status
Recruiting
Study Info
Age
18 - 55 Years
Condition
  • Cardiovascular Disease
    • Sex
    All
    Trial Dates
    May 2017 - Nov 2017
    Inclusion and Exclusion Criteria
    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