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

• Status: Completed
• Trial end date: 2015-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: OncoImmune, Inc.
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

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.