First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL

Inclusion criteria

• Male or female (with no possibility to become pregnant (hysterectomized or menopausal women)) subjects who give their written consent to participate in the study.
• Aged from 18 to 55.
• No clinically significant organic or psychic conditions.
• No clinically significant abnormalities in medical records and physical examination.
• No clinically significant abnormalities in haematology, coagulation, biochemistry, serology and urinalysis .
• No clinically significant abnormalities in vital signs and electrocardiogram.

Exclusion criteria

• Subjects affected by an organic or psychic condition.
• Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication
• Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
• History of sensitivity to any drug.
• Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
• Smoker.
• Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
• Having donated blood in the last month before start of the study.
• Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
• Inability to follow the instructions or collaborate during the study.