AMG 529 First in Human Study

Cardiovascular Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170193
• Other study ID #: 20160338
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: April 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular

Intervention

Drug:
• AMG 529
Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection
• Placebo
Single doses of matching placebo by SC or IV injection

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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.	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	Maximum Observed Concentration (Cmax) of AMG 529		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.
Secondary	Time to Maximum Observed Concentration (Tmax) of AMG 529		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.
Secondary	Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529		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.
Secondary	Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time		Baseline and days 3, 8, and 30
Secondary	Change From Baseline in Total Cholesterol Concentration Over Time		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.
Secondary	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time		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.
Secondary	Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time		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.
Secondary	Change From Baseline in Triglycerides Concentration Over Time		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.

External Links

•   AmgenTrials clinical trials website