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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05873907
Collaborator
(none)
64
Enrollment
1
Location
9
Arms
21.3
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: AMG 592
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Oct 19, 2015
Actual Primary Completion Date :
Jun 16, 2017
Actual Study Completion Date :
Jul 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 592: Dose 1

Administered as a single dose subcutaneous (SC) injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 2

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 3

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 4

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 5

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 6

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 7

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Experimental: AMG 592: Dose 8

Administered as a single dose SC injection.

Drug: AMG 592
Administered as SC injection
Placebo Comparator: Placebo

Administered as SC injection.

Other: Placebo
Administered as SC injection

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Day 1 up to Day 57]

    Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.

  2. Number of Participants with Anti-AMG 592 Antibodies [Day 1 up to Day 57]

  3. Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs) [One week after AMG 592 administration (up to 7 days)]

  4. Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons) [One week after AMG 592 administration (up to 7 days)]

  5. Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs) [One week after AMG 592 administration (up to 7 days)]

Secondary Outcome Measures

  1. Maximum Observed Serum Concentration (Cmax) of AMG 592 [Day 1 up to Day 57]

  2. Time of Maximum Observed Concentration (tmax) of AMG 592 [Day 1 up to Day 57]

  3. Area Under the Concentration-time Curve (AUC) of AMG 592 [Day 1 up to Day 57]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Aventura Florida United States 33180

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05873907
Other Study ID Numbers:
  • 20140324
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
Chronic Graft-versus-Host Disease
AMG 592
Inflammatory Conditions
Additional relevant MeSH terms:
Bronchiolitis Obliterans Syndrome
Graft vs Host Disease

Study Results

No Results Posted as of May 24, 2023