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Completed

NCT Number: NCT05873907

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Aventura, Florida, 33180, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 592

Drug

Administered as SC injection

Placebo

Other

Administered as SC injection

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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

    Time frame: Day 1 up to Day 57

  3. 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)

  4. 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)

  5. 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 outcomes

  1. Maximum Observed Serum Concentration (Cmax) of AMG 592

    Time frame: Day 1 up to Day 57

  2. Time of Maximum Observed Concentration (tmax) of AMG 592

    Time frame: Day 1 up to Day 57

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

    Time frame: Day 1 up to Day 57

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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