AMG 529 First in Human Study

NCT03170193 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20160338
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

• 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.

• 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.

• Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time

  Baseline and days 3, 8, and 30

• 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.

Study Arms (2)

AMG 529

EXPERIMENTAL

Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.

Drug: AMG 529

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.

Drug: Placebo

Interventions

AMG 529 DRUG

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

AMG 529

Placebo DRUG

Single doses of matching placebo by SC or IV injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Research Site

Overland Park, Kansas, 66212, United States

Location

Related Links

• AmgenTrials clinical trials website

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: May 15, 2017
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-04

Locations

US (1)