A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers

Exclusion Criteria

• •Subjects were eligible for enrollment in the study only if they meet none of the following criteria:
• •1. The subject had a history of severe allergic or anaphylactic reactions.
• •2. The subject had a known allergy or hypersensitivity to any component of the formulation.
• •3. The subject had a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transpeptidase \[GGT\], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
• •4. The subject had a history of any malignant disease.
• •5. The subject had a history of more than one herpes zoster episode or multidermatomal herpes zoster.
• •6. The subject had a history of an opportunistic infection (e.g. cytomegalovirus, pneumocystis carinii, aspergillosis, clostridium difficile).
• •7. The subject had a history of or ongoing chronic or recurrent infectious disease (e.g. infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
• •8. The subject had major trauma or surgery in the 2 months before screening or at any time between screening and check-in.
• •9. The subject had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (eg, mild rhinorrhea), untreated oral/dental abnormalities (e.g. untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin.
• •10. The subject had clinically significant abnormal ECG findings at screening, check-in visits, or predose, as determined by the Investigator.
• •11. The subject had a supine blood pressure measurement outside the ranges of 90 to 140 mm Hg systolic or 45 to 90 mm Hg diastolic (measured after a rest of at least 5 minutes) at screening, check-in, or predose. Note: If either value was out of the range, blood pressure measurements may be repeated in the supine position at intervals of 5 to 10 minutes up to 3 times. If the mean systolic or diastolic measurement continues to exceed the stated limits, the subject will be excluded.
• •12. The subject had a pulse of fewer than 45 beats per minute (bpm) or greater than 100 bpm(measured after a rest of at least 5 minutes) at screening, check-in, or predose.
• •13. The subject tests positive for tuberculosis (TB) at screening by the QuantiFERON-TB Gold Test, or has a history of latent, inadequately treated, or active TB.
• •14. The subject had a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.
• •15. The subject had used prescription or over-the-counter (OTC) medication (other than ≤2 g/day paracetamol \[acetaminophen\] or ≤800 mg/day ibuprofen), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever was longer.
• •16. The subject had participated in another clinical study of a new investigational drug or has received an investigational drug within the 3 months or 5 half-lives (if available) before study drug administration, whichever is longer.
• •17. The subject had a loss of more than 400 mL of blood (e.g. a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before check-in, or plans to donate blood during the study or within 3 months after the study.
• •18. The subject had a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1 single shot of spirits. The subject will be required to abstain from alcohol consumption 48 hours prior to screening or check-in.
• •19. The subject was a current smoker or has a history of smoking.
• •20. The subject had a positive test for alcohol or drugs of abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) at screening or check-in.
• •21. The subject was unable to participate in, or successfully complete, the study, in the opinion of their general practitioner or the investigator, because the subject was any of the following:
• •1. mentally or legally incapacitated, or unable to give consent for any reason
• •2. in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution
• •3. unable to be contacted in case of emergency
• •4. unlikely to cooperate or comply with the clinical study protocol or was unsuitable for any other reason