Clinical trial NCT05873907: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Graft-versus-host Disease (cGVHD)
Keywords: Chronic Graft-versus-Host Disease
AMG 592
Inflammatory Conditions
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Day 57
measure: Number of Participants with Anti-AMG 592 Antibodies
timeFrame: Day 1 up to Day 57
measure: Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
timeFrame: One week after AMG 592 administration (up to 7 days)
measure: Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
timeFrame: One week after AMG 592 administration (up to 7 days)
measure: Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
timeFrame: One week after AMG 592 administration (up to 7 days)
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of AMG 592
timeFrame: Day 1 up to Day 57
measure: Time of Maximum Observed Concentration (tmax) of AMG 592
timeFrame: Day 1 up to Day 57
measure: Area Under the Concentration-time Curve (AUC) of AMG 592
timeFrame: Day 1 up to Day 57
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: