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A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants

Primary Purpose

Chronic Graft-versus-host Disease (cGVHD)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 592
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Graft-versus-host Disease (cGVHD) focused on measuring Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Males must agree to practice an acceptable method of effective birth control while on study through 2 weeks after receiving the dose of study drug. Males must be willing to abstain from sperm donation while on study through 2 weeks after receiving the (last [multiple dose studies]) dose of study drug. Male and female subjects ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at the time of screening. Females must be of non-reproductive potential (ie, postmenopausal - age ≥ 55 years with cessation of menses for 12 months or more, or according to the definition of "postmenopausal range" for the laboratory involved OR history of hysterectomy; OR history of bilateral oophorectomy). Exclusion Criteria: Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive). Positive results for Human Immunodeficiency Virus (HIV). Participant has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or participant has a positive purified protein derivative (PPD) or QuantiFERON or T-Spot test at Screening. Participants with a documented negative PPD or QuantiFERON or T-Spot test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening. Currently receiving treatment in another investigational device or drug study, or less than 30 days or less than 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study. Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1. Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the dose of study drug. Female participants with a positive pregnancy test. Males with partners who are pregnant or planning to become pregnant while the participant is on study through 2 weeks after receiving the dose of study drug. Has any significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation that in the opinion of the Investigator, in consultation with the Amgen Medical Monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including Screening). Is a current smoker, has used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months from Screening, and cumulative smoking history is ≥ 10 pack years. Unwilling or unable to refrain from strenuous exercise (eg, heavy lifting, weight training, and aerobics) for 72 hours prior to each visit that includes blood collection. Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP. Participants with a known history of autoimmune disease.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AMG 592: Dose 1

AMG 592: Dose 2

AMG 592: Dose 3

AMG 592: Dose 4

AMG 592: Dose 5

AMG 592: Dose 6

AMG 592: Dose 7

AMG 592: Dose 8

Placebo

Arm Description

Administered as a single dose subcutaneous (SC) injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as a single dose SC injection.

Administered as SC injection.

Outcomes

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
Number of Participants with Anti-AMG 592 Antibodies
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of AMG 592
Time of Maximum Observed Concentration (tmax) of AMG 592
Area Under the Concentration-time Curve (AUC) of AMG 592

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05873907
Brief Title
A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
Official Title
A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2015 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-host Disease (cGVHD)
Keywords
Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 592: Dose 1
Arm Type
Experimental
Arm Description
Administered as a single dose subcutaneous (SC) injection.
Arm Title
AMG 592: Dose 2
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 3
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 4
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 5
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 6
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 7
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
AMG 592: Dose 8
Arm Type
Experimental
Arm Description
Administered as a single dose SC injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered as SC injection.
Intervention Type
Drug
Intervention Name(s)
AMG 592
Intervention Description
Administered as SC injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered as SC injection
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
Time Frame
Day 1 up to Day 57
Title
Number of Participants with Anti-AMG 592 Antibodies
Time Frame
Day 1 up to Day 57
Title
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Time Frame
One week after AMG 592 administration (up to 7 days)
Title
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Time Frame
One week after AMG 592 administration (up to 7 days)
Title
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
Time Frame
One week after AMG 592 administration (up to 7 days)
Secondary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of AMG 592
Time Frame
Day 1 up to Day 57
Title
Time of Maximum Observed Concentration (tmax) of AMG 592
Time Frame
Day 1 up to Day 57
Title
Area Under the Concentration-time Curve (AUC) of AMG 592
Time Frame
Day 1 up to Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males must agree to practice an acceptable method of effective birth control while on study through 2 weeks after receiving the dose of study drug. Males must be willing to abstain from sperm donation while on study through 2 weeks after receiving the (last [multiple dose studies]) dose of study drug. Male and female subjects ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at the time of screening. Females must be of non-reproductive potential (ie, postmenopausal - age ≥ 55 years with cessation of menses for 12 months or more, or according to the definition of "postmenopausal range" for the laboratory involved OR history of hysterectomy; OR history of bilateral oophorectomy). Exclusion Criteria: Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive). Positive results for Human Immunodeficiency Virus (HIV). Participant has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or participant has a positive purified protein derivative (PPD) or QuantiFERON or T-Spot test at Screening. Participants with a documented negative PPD or QuantiFERON or T-Spot test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening. Currently receiving treatment in another investigational device or drug study, or less than 30 days or less than 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study. Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1. Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the dose of study drug. Female participants with a positive pregnancy test. Males with partners who are pregnant or planning to become pregnant while the participant is on study through 2 weeks after receiving the dose of study drug. Has any significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation that in the opinion of the Investigator, in consultation with the Amgen Medical Monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including Screening). Is a current smoker, has used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months from Screening, and cumulative smoking history is ≥ 10 pack years. Unwilling or unable to refrain from strenuous exercise (eg, heavy lifting, weight training, and aerobics) for 72 hours prior to each visit that includes blood collection. Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP. Participants with a known history of autoimmune disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants

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