A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
Phase 1
Completed
- Conditions
- Chronic Graft-versus-host Disease (cGVHD)
- Interventions
- Other: Placebo
- Registration Number
- NCT05873907
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMG 592: Dose 1 AMG 592 Administered as a single dose subcutaneous (SC) injection. AMG 592: Dose 2 AMG 592 Administered as a single dose SC injection. AMG 592: Dose 3 AMG 592 Administered as a single dose SC injection. AMG 592: Dose 7 AMG 592 Administered as a single dose SC injection. AMG 592: Dose 8 AMG 592 Administered as a single dose SC injection. Placebo Placebo Administered as SC injection. AMG 592: Dose 4 AMG 592 Administered as a single dose SC injection. AMG 592: Dose 5 AMG 592 Administered as a single dose SC injection. AMG 592: Dose 6 AMG 592 Administered as a single dose SC injection.
- Primary Outcome Measures
Name Time Method 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.
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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Aventura, Florida, United States