Safety Study of Efprezimod Alfa (CD24Fc, MK-7110) When Administered Intravenously in Healthy Adult Subjects (MK-7110-001)

NCT02650895 | Completed Phase 1 Results

• 3 other identifiers: 7110-0011R01NS080821CD24Fc-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring

  List of adverse events in the form of frequency and grade. Assessment of safety based primarily on the frequency and nature of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, 12-lead ECGs, and telemetry monitoring from pre-dosing to day 42 visits. The data include all treatment-emergent adverse events (TEAEs) including specific drug-related TEAEs.

  Up to 42 days after treatment

Secondary Outcomes (4)

• Serum Concentration of CD24Fc Over Time

  Up to 42 days after treatment

• Maximum Serum Concentration (Cmax) of CD24Fc

  Up to 42 days after treatment

• Area Under the Serum Concentration Curve From 0-42 Days (AUC 0-42d) of CD24Fc

  Up to 42 days after treatment

• Terminal Elimination Half-Life (t1/2) of CD24Fc

  Up to 42 days after treatment

Study Arms (2)

Efprezimod alfa

EXPERIMENTAL

Single dose of efprezimod alfa is administrated as intravenous infusion in one hour. There are 5 dose cohorts, 10mg, 30mg, 60mg, 120mg, 240mg. Each cohort has 6 subjects in efprezimod alfa and 2 subject in placebo.

Biological: Efprezimod alfa

Saline

PLACEBO COMPARATOR

Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour.

Drug: Saline

Interventions

Efprezimod alfa BIOLOGICAL

Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain

Also known as: CD24IgG, CD24Fc, MK- 7110

Efprezimod alfa

Saline DRUG

0.9% sodium chloride

Also known as: Normal saline

Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Medpace Clinical Pharmacology Unit (CPU)

Cincinnati, Ohio, 45227, United States

Location

Related Publications (1)

• Wang X, Liu M, Zhang J, Brown NK, Zhang P, Zhang Y, Liu H, Du X, Wu W, Devenport M, Tao W, Mao-Draayer Y, Chen GY, Chen YE, Zheng P, Liu Y. CD24-Siglec axis is an innate immune checkpoint against metaflammation and metabolic disorder. Cell Metab. 2022 Aug 2;34(8):1088-1103.e6. doi: 10.1016/j.cmet.2022.07.005.

  PMID: 35921817 DERIVED

Related Links

• Description: Merck Oncology Clinical Trials Information

MeSH Terms

Interventions

Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Pan Zheng
• Organization: OncoImmune, Inc.

pzheng@oncoimmune.com

2027516823

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: June 2, 2014
• Primary Completion: January 15, 2015
• Study Completion: January 15, 2015
• Last Updated: January 12, 2023
• Results First Posted: January 29, 2020

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)