Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Exclusion Criteria

• •1. Evidence or history of clinically relevant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies,). This includes any acute or chronic medical or psychiatric condition or laboratory abnormality.
• •2. History or current drug/alcohol abuse. History of regular alcohol consumption exceeding - 14 drinks/week for men (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months of screening.
• •3. Hypereosinophilia defined as peripheral blood Eosinophils \> 4.5×108/L (450/μl) or exceeding 7% of the circulating leukocytes.
• •4. Positive urine drugs of abuse (DoA) test during screening and on admission.
• •5. Positive breath alcohol test on admission.
• •6. Known acute or chronic allergy to any drug or hypersensitivity to any of the test formulation compounds or contraindication to the test product.
• •7. Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol for symptomatic relief of pain is allowed up to 24 hours prior to study drug administration.
• •8. Having received any biological treatment with recombinant antibodies, immunological therapy, or anticancer treatment. Previous standard vaccination treatment is allowed.
• •9. Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening.
• •10. Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.
• •11. Participation in another clinical trial within 3 months prior to dosing (calculated from the previous study's last dosing day).
• •12. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of dosing.
• •13. Subjects with an inability to communicate well with the investigators and CRC staff (e.g., language problem, poor mental development).