Safety Study of CD24Fc When Administered Intravenously in Healthy Adult Subjects (MK-7110-001)
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|ClinicalTrials.gov Identifier: NCT02650895|
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : January 29, 2020
Last Update Posted : August 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: CD24Fc Drug: Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
0.9% sodium chloride
Other Name: Normal saline
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Ohio|
|Medpace Clinical Pharmacology Unit (CPU)|
|Cincinnati, Ohio, United States, 45227|
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|