NCT05873907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

May 16, 2023

Last Update Submit

May 16, 2023

Conditions

Chronic Graft-versus-host Disease (cGVHD)

Keywords

Chronic Graft-versus-Host DiseaseAMG 592Inflammatory Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    Day 1 up to Day 57

  • Number of Participants with Anti-AMG 592 Antibodies

    Day 1 up to Day 57

  • Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)

    One week after AMG 592 administration (up to 7 days)

  • Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)

    One week after AMG 592 administration (up to 7 days)

  • Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)

    One week after AMG 592 administration (up to 7 days)

Secondary Outcomes (3)

  • Maximum Observed Serum Concentration (Cmax) of AMG 592

    Day 1 up to Day 57

  • Time of Maximum Observed Concentration (tmax) of AMG 592

    Day 1 up to Day 57

  • Area Under the Concentration-time Curve (AUC) of AMG 592

    Day 1 up to Day 57

Study Arms (9)

AMG 592: Dose 1

EXPERIMENTAL

Administered as a single dose subcutaneous (SC) injection.

Drug: AMG 592

AMG 592: Dose 2

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 3

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 4

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 5

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 6

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 7

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

AMG 592: Dose 8

EXPERIMENTAL

Administered as a single dose SC injection.

Drug: AMG 592

Placebo

PLACEBO COMPARATOR

Administered as SC injection.

Other: Placebo

Interventions

AMG 592DRUG

Administered as SC injection

AMG 592: Dose 1AMG 592: Dose 2AMG 592: Dose 3AMG 592: Dose 4AMG 592: Dose 5AMG 592: Dose 6AMG 592: Dose 7AMG 592: Dose 8
PlaceboOTHER

Administered as SC injection

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Aventura, Florida, 33180, United States

Location

Related Links

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 24, 2023

Study Start

October 19, 2015

Primary Completion

June 16, 2017

Study Completion

July 28, 2017

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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.
More information

Locations

US(1)