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AMG 529 First in Human Study

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ClinicalTrials.gov Identifier: NCT03170193
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Cardiovascular Drug: AMG 529 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : November 17, 2017

Arm Intervention/treatment
Experimental: AMG 529
Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.
Drug: AMG 529
Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection

Placebo Comparator: Placebo
Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.
Drug: Placebo
Single doses of matching placebo by SC or IV injection




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170193


Locations
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United States, Kansas
Research Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] May 1, 2017
Statistical Analysis Plan  [PDF] July 20, 2017


Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03170193     History of Changes
Other Study ID Numbers: 20160338
First Posted: May 30, 2017    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No