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

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.

Official Title
-----------------
First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: ApTOLL


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ApTOLL treatment<br>Volunteers will receive a dose of ApTOLL of 0.1mg/kg administered intravenously as slow infusion one day and as a single bolus intravenous injection the second day. In a third and last admission day, volunteers will receive a dose of ApTOLL of 0.2mg/kg administered as a single bolus intravenous injection. | Drug: ApTOLL<br>* ApTOLL will be administered as follows: Day 1: a dose of 0.1mg/kg will be administered intravenously as a slow infusion. Day 2: a dose of 0.1mg/kg will be administered intravenously as single bolus injection. Day 3: a dose of 0.2mg/kg will be administered intravenously as single bolus injection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To evaluate the safety and tolerability between different ways of ApTOLL administration: intravenous infusion versus bolus intravenous injection, and pharmacokinetic characteristics of ApTOLL in healthy volunteers after single dose administration in fasting conditions. | day 1 to day 28 |