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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02650895
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : January 29, 2020
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
OncoImmune, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of CD24Fc in healthy adult participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: CD24Fc Drug: Saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CD24Fc When Administered Intravenously in Healthy Adult Subjects
Actual Study Start Date : June 2, 2014
Actual Primary Completion Date : January 15, 2015
Actual Study Completion Date : January 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: CD24Fc
Single dose of CD24Fc is administrated as intravenous infusion in one hour. There are 5 dose cohorts, 10mg, 30mg, 60mg, 120mg, 240mg. Each cohort has 6 subjects in CD24Fc and 2 subject in placebo.
Biological: CD24Fc
Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
Other Name: CD24IgG

Placebo Comparator: Saline
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour.
Drug: Saline
0.9% sodium chloride
Other Name: Normal saline




Primary Outcome Measures :
  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 [ Time Frame: Up to 42 days after treatment ]
    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.


Secondary Outcome Measures :
  1. Serum Concentration of CD24Fc Over Time [ Time Frame: Up to 42 days after treatment ]
    Measurement of serum CD24Fc concentration at different time points after administration.

  2. Maximum Serum Concentration (Cmax) of CD24Fc [ Time Frame: Up to 42 days after treatment ]
    Assessment of CD24Fc pharmacokinetics based on serum CD24Fc concentration at different time points after administration to determine drug Cmax. Cmax was defined as the maximum concentration of CD24Fc observed in serum following administration of CD24Fc.

  3. Area Under the Serum Concentration Curve From 0-42 Days (AUC 0-42d) of CD24Fc [ Time Frame: Up to 42 days after treatment ]
    AUC was defined as the area of serum concentration versus time curve from time zero to 42 days (AUC 0-42d). Assessment of AUC 0-42d was based on CD24Fc concentration measured at different time points after administration of CD24Fc.

  4. Terminal Elimination Half-Life (t1/2) of CD24Fc [ Time Frame: Up to 42 days after treatment ]
    t1/2 was defined as the time required to divide the serum concentration by two after reaching maximum concentration (Cmax), following administration of CD24Fc.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650895


Locations
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United States, Ohio
Medpace Clinical Pharmacology Unit (CPU)
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
OncoImmune, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: OncoImmune, Inc.
ClinicalTrials.gov Identifier: NCT02650895    
Other Study ID Numbers: 7110-001
1R01NS080821 ( U.S. NIH Grant/Contract )
CD24Fc-001 ( Other Identifier: OncoImmune )
First Posted: January 8, 2016    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: August 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php