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Completed

NCT Number: NCT03170193

AMG 529 First in Human Study

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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Key information

Conditions

Cardiovascular

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AMG 529

Drug

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

Placebo

Drug

Single doses of matching placebo by SC or IV injection

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.

    Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal.

    A serious adverse event was defined as an adverse event that met at least 1 of the following criteria:

    • fatal
    • life threatening
    • required in patient hospitalization or prolongation of existing hospitalization
    • resulted in persistent or significant disability/incapacity
    • congenital anomaly/birth defect
    • other medically important serious event.

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of AMG 529

    Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.

  2. Time to Maximum Observed Concentration (Tmax) of AMG 529

    Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.

  3. Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529

    Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.

  4. Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time

    Time frame: Baseline and days 3, 8, and 30

  5. Change From Baseline in Total Cholesterol Concentration Over Time

    Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

  6. Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time

    Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

  7. Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time

    Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

  8. Change From Baseline in Triglycerides Concentration Over Time

    Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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