Clinical trial NCT03170193: AMG 529 First in Human Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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.
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of AMG 529
timeFrame: 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.
measure: Time to Maximum Observed Concentration (Tmax) of AMG 529
timeFrame: 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.
measure: Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529
timeFrame: 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.
measure: Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
timeFrame: Baseline and days 3, 8, and 30
measure: Change From Baseline in Total Cholesterol Concentration Over Time
timeFrame: 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.
measure: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
timeFrame: 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.
measure: Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
timeFrame: 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.
measure: Change From Baseline in Triglycerides Concentration Over Time
timeFrame: 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.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: