Single Ascending Dose Study of AMG 570 in Healthy Subjects

NCT02618967 | Completed Phase 1 Results

• 1 other identifier: 20140322
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus; Healthy Volunteer; Safety Study; Placebo Control; Phase 1

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)

  TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event

  Day 1 to Day 105

• Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations

  Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).

  Baseline to Day 105

• Number of Participants Who Experienced a Clinically Significant Change in Vital Signs

  Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.

  Baseline to Day 105

• Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests

  Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.

  Baseline to Day 105

• Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)

  Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.

  Baseline to Day 105

Secondary Outcomes (8)

• Maximum Observed Concentration (Cmax) of AMG 570

  Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105

• Time to Reach Maximum Observed Concentration (Tmax) of AMG 570

  Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105

• Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570

  Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105

• Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570

  Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105

• Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result

  Baseline to Day 105

Study Arms (8)

AMG 570 - 7 mg

EXPERIMENTAL

Participants will receive a single dose 7 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 21 mg

EXPERIMENTAL

Participants will receive a single 21 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 70 mg

EXPERIMENTAL

Participants will receive a single 70 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 140 mg

EXPERIMENTAL

Participants will receive a single 140 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 210 mg

EXPERIMENTAL

Participants will receive a single 210 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 420 mg

EXPERIMENTAL

Participants will receive a single 420 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

AMG 570 - 700 mg

EXPERIMENTAL

Participants will receive a single 700 mg dose of AMG 570 administered subcutaneously.

Biological: AMG 570

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of the matching AMG 570 placebo administered subcutaneously.

Biological: AMG 570 Matching Placebo

Interventions

AMG 570 BIOLOGICAL

7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.

Also known as: Active Comparator, Investigational Product, and Study drug

AMG 570 - 140 mg; AMG 570 - 21 mg; AMG 570 - 210 mg; AMG 570 - 420 mg; AMG 570 - 7 mg; AMG 570 - 70 mg; AMG 570 - 700 mg

AMG 570 Matching Placebo BIOLOGICAL

Placebo administered as single dose subcutaneous in healthy volunteers.

Also known as: Placebo, Investigational Product, and Study drug

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as determined by the investigator
• Normal or clinically acceptable electrocardiogram (ECG)
• Female subjects must be of documented non-reproductive potential
• Subjects must be current for all vaccinations

You may not qualify if:

• Current or chronic history of liver disease
• History of active infections
• History of significant respiratory disorder
• Evidence of renal disease

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Research Site

Evansville, Indiana, 47710, United States

Location

Research Site

Overland Park, Kansas, 66212, United States

Location

Research Site

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.

  PMID: 37150935 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

rozibafusp alfa; Drug Evaluation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: December 2, 2015
• Study Start: March 28, 2016
• Primary Completion: September 6, 2018
• Study Completion: December 3, 2018
• Last Updated: May 14, 2024
• Results First Posted: October 15, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (3)