Status:
COMPLETED
First in Human Clinical Trial of ApTOLL in Healthy Volunteers
Lead Sponsor:
aptaTargets S.L.
Collaborating Sponsors:
Ministry of Science and Innovation, Spain
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Conditions:
Stroke
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a Phase I, first-in-human, dose ascending, randomized, placebo-controlled clinical study to assess the tolerability and pharmacokinetics of ApTOLL in healthy volunteers. ApTOLL is an aptamer a...
Detailed Description
This Phase I clinical trial is divided in two parts: the first part (part A) is a single dose escalation study and the second (part B) is a multiple dose study. Both are performed in healthy volunteer...
Eligibility Criteria
Inclusion
- Male or female subjects (women without possibility of becoming pregnant) willing and able to give their written consent to participate in the trial.
- Healthy subjects aged within: 18 to 55 years (limits included).
- Clinical history and physical examination results within normality.
- Vital signs and electrocardiogram without clinically significant pathologic abnormalities and with QTc (Corrected QT space) values lower than 450 ms.
- Body weight between 65 and 85 kg, inclusive.
- BMI (Body Mass Index) between 19.0 and 30.0 kg/m2.
- No clinically significant abnormalities in haematology, biochemistry, serology (Ag HBV (Hepatitis B Virus), HCV (Hepatitis C Virus) antibodies, HIV (Human Immunodeficiency Virus) antibodies) and urine tests.
Exclusion
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment.
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
- Subject having at screening examination a sitting blood pressure more than or equal to 140/90 mm Hg or lower than or equal to 90/50 mmHg.
- Subject having at screening examination a pulse more than 100 beats per minute or a body temperature more than 37.7 °C. or a respiratory rate outside the normal range of (14-20 breath per minute).
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
- Clinically significant abnormalities in screening laboratory tests.
- Any prescription, over-the-counter and herbal medications within 10 days prior to study dosing.
- Use of an investigational drug within 3 months prior to dosing in this study.
- Psychiatric history of current or past psychosis, bipolar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
- Pregnant or breastfeeding women.
- History of substance abuse, including alcohol.
- Smokers.
- History of substance or drug dependence, or positive urine drug screen at screening visit.
- History of head injury.
- History of sensitivity to any drug.
- Having donated blood in the last month before start of the study.
- Any reason or opinion of the investigator that would prevent the subject from participation in the study.
- Inability to follow the instructions or an unwillingness to collaborate during the study.
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04742062
Start Date
July 18 2019
End Date
March 20 2020
Last Update
March 17 2022
Active Locations (1)
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1
Clinical Pharmacology Department. Hospital Universitario de La Princesa
Madrid, Spain, 28006