An Ascending-dose, Randomized, Placebo-controlled, Parallel, Double-blind, Single-dose, First-in-Human Study to Evaluate the Safety and Pharmacokinetics of RECCE®327 in Healthy Male Subjects

Exclusion Criteria31

• Subjects meeting one or more of the following criteria will be excluded from the study:
• Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, renal disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the Investigator (or Designee) considers should exclude the subject or that could interfere with the interpretation of the study results.
• Subjects with history of or current condition of any of the following will be excluded: Gilbert’s syndrome, asthma or reactive airway disease (any age), migraine;
• Subjects with history of cholecystectomy or splenectomy, or other completely resolved medical conditions may be included at the discretion of the Investigator (or Designee) and the Sponsor.
• Has any clinically significant medical condition, physical examination finding, ECG abnormality, or clinically significant abnormal value for clinical chemistry, hematology, coagulation, or urinalysis at Screening or at admission to the study center, as deemed appropriate by the Investigator (or Designee).
• Has had any history of clotting or coagulation disorder.
• Has had any history of clinically significant renal disease.
• History or presence of malignancy within the past 5 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
• Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, including but not limited to:
• A history of anaphylactic reaction
• Allergic (histamine-like) reaction due to any drug that led to significant morbidity
• Known hypersensitivity to any component of the formulation of test article (RECCE®327), reference (placebo) article, or pretreatment article(s).
• Has donated or intends to donate blood or blood products or has had an acute loss of blood (>500 mL) during the 3 months before study drug administration, or intends to donate blood or blood products within 3 months after the completion of the study.
• Has had an acute, clinically significant illness within 30 days prior to Day 1, or has had a recent febrile illness with an abnormal body temperature within 72 hours prior to admission.
• Has a history within the past 24 months before Screening of drug abuse (defined as any illicit drug use), or a history of alcohol abuse (defined as alcohol consumption exceeding 10 units per week). One unit of alcohol equals 360 mL (12 oz) of beer, 45 mL (1.5 oz) of liquor, or 150 mL (5 oz) of wine.
• Has a positive test for alcohol or drugs of abuse at Screening or upon admittance to the testing facility, or is unwilling to abstain from alcohol and drugs of abuse throughout the study.
• Has a smoking history during the past 6 months before Screening. This includes the use of any nicotine containing substances (e.g., nicotine patch or gum, chewing tobacco, e-cigarettes), or has a positive cotinine test at Screening or at admission, or is unwilling to abstain from these products for the duration of the study.
• Has used any investigational compound, an experimental medical device, or participated in another clinical trial (randomized subjects only) within 3 months prior to receiving the study drug.
• If the male subject intends to impregnate others or donate sperm within 90 days (3 months) after receiving the study drug.
• Has inadequate venous access for the required blood draws for the study.
• Is unable to meet or perform study requirements, or has a known or suspected inability to comply with the study protocol.
• Is an immediate family member of the Investigator, or is an employee of the study center, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• Use of a significantly abnormal diet (including keto diet) during the 4 weeks prior to receiving the study medication until the EOS visit.
• Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 14 days prior to receiving the study medication until the EOS visit.
• Use of Vitamin K supplements or any drug which affects coagulation within 14 days prior to receiving the study medication until the EOS visit.
• Use of any prescription medication from 14 days or 5 half-lives of the medication, whichever is longer, prior to receiving the study medication until the EOS visit.
• Receipt of any vaccination within 14 days prior to receiving the study medication until the EOS visit.
• Engagement in non-routine strenuous exercise or sunbathing from 48 hours prior to receiving the study medication until the EOS visit.
• Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 3 days prior to admission until the EOS visit. Subjects will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug.
• Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
• Subjects who, in the opinion of the Investigator (or Designee), should not participate in this study.