Safety Study of Efprezimod Alfa (CD24Fc, MK-7110) When Administered Intravenously in Healthy Adult Subjects (MK-7110-001)
Condition: Healthy Volunteers
Intervention: Efprezimod alfa; Saline
Intervention description: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain; 0.9% sodium chloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of single ascending
      intravenous (IV) doses of efprezimod alfa in healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female volunteers between the ages of 18 and 55 years, inclusive, in
             good health based on medical history, physical examination, electrocardiogram (ECG),
             and routine laboratory tests (blood chemistry, hematology, urinalysis, and drug
             screen). Any routine laboratory test could be repeated per Investigator judgment;

          -  Body mass index (BMI) between 18 kg/m2 and 30 kg/m2, inclusive;

          -  Participants must have been non-smokers or had quit smoking >6 months prior to
             Screening;

          -  Women of childbearing potential with a negative urine pregnancy test at Screening who
             were not breastfeeding, did not plan to become pregnant during the study, and agreed
             to use dual methods of birth control during the study (i.e., 2 of the following:
             diaphragm or cervical cap with spermicide, intrauterine device [IUD] hormonal
             contraceptives [stable for at least 3 months prior to Screening], male partner using
             condom with spermicide) from Day 1 until 60 days following the administration of study
             drug; or female participants of non-childbearing potential were either surgically
             sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or >1 year
             post-menopausal with a follicle-stimulating hormone (FSH) in the post menopausal range
             (post-menopausal taking hormone replacement therapy [stable for at least 3 months
             prior to Screening] did not require an FSH level);

          -  All male participants were required to use barrier contraception (condom with
             spermicide) in addition to having their female partner (if of childbearing potential)
             use another acceptable form of contraception (IUD, diaphragm with spermicide, hormonal
             contraceptives [stable for at least 3 months prior to Screening]) from Day 1 until 60
             days following the last administration of study drug;

          -  Negative alcohol, cotinine, and drug screen;

          -  Willing to abstain from alcohol for 48 hours prior to any visit;

          -  Willing and able to be confined to the CPU as required by the protocol;

          -  Willing and able to comply with the investigational nature of the study and able to
             communicate well with the Principal Investigator and clinical staff; and

          -  Ability to comprehend and willingness to provide written informed consent in
             accordance with institutional and regulatory guidelines.

        Exclusion Criteria:

          -  Participants with evidence or history of clinically significant immunologic,
             hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
             psychiatric, neurologic, or allergic disease (including drug allergies), surgical
             conditions, cancer or any other condition that, in the Investigator's opinion, might
             significantly interfere with the absorption, distribution, metabolism, or excretion of
             the study drug;

          -  Participants who had received any investigational drug or device within 30 days or
             less than 5 half-lives of investigational drug prior to dosing;

          -  Participants taking any prescription or over-the-counter medications within 7 days
             prior to dosing, or were not willing to refrain from these medications throughout the
             study period;

          -  Participants who had a history of alcoholism or drug abuse within 2 years prior to
             dosing;

          -  Participants with a typical consumption of 14 alcoholic drinks weekly;

          -  Participants who had a history of or positive tests for human immunodeficiency virus
             (HIV) or hepatitis C virus (HCV), or participants who had a positive hepatitis B
             surface antigen (HBsAg) at Screening;

          -  Participants who had donated blood or blood products within 30 days prior to dosing;

          -  Participants with inadequate venous access;

          -  Participants with an aspartate aminotransferase (AST) or alanine aminotransferase
             (ALT) >2 the upper limit of normal (ULN) at Screening or Day -1;

          -  Participants with a total bilirubin >1.5 ULN at Screening or Day -1;

          -  Participants who were currently undergoing treatment with weight loss medication or
             prior weight loss surgery (e.g., gastric bypass surgery);

          -  Participants who had poor mental function or any other reason to expect participant
             difficulty in complying with the requirements of the study; or

          -  Participants who had a history or presence of any medical condition or disease that,
             in the opinion of the Investigator, could interfere with the conduct of the study or
             would put the participant at unacceptable risk.