Clinical trial NCT06715163: Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers
Official title: Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Tolerability in Healthy Volunteers
Keywords: safety
tolerability
diamino oxidase
DAO
supplementation
Lead sponsor: AB Biotek
Sponsor class: INDUSTRY
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2024-12-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this study is to evaluate the safety and tolerability of the product administered, of 3 different doses. Safety will be evaluated by recording and assessing adverse events, vital signs, laboratory tests and ECG. These assessments will be conducted during the study and at the end the study, following the study schedule and evaluation times. Since it is not absorbed and considering the conducted studies, 24 h are sufficient to analyse the safety and tolerability of the product. Safety will be assessed until the follow up visit, 6-8 days after product intake, to check possible adverse effects during that time.


Eligibility criteria: Inclusion Criteria:

1. - Subjects of either gender (male or female) aged ≥18 and ≤50 years at the time of the enrolment.
2. - Subjects free from organic or psychic conditions.
3. - No clinically significant abnormalities in medical records and physical examination at screening.
4. - No clinically significant abnormalities in haematology, biochemistry, serology (HBsAg, HCV antibodies, HIV antibodies) and urine drug results.
5. - Vital signs (blood pressure, respiratory rate, body temperature and pulse rate) and electrocardiogram record without clinically significant abnormalities.
6. - Body weight within the range (BMI ≥ 18.5 and ≤30.0 kg/m2) expressed as weight (kg) / height (m2).
7. - Free acceptance to participate in the study by obtaining signed informed consent form approved by the Ethics Committee of the Hospital (CEIm).

Exclusion Criteria:

1. - Background of allergy, idiosyncrasy or hypersensitivity to Investigational or any products or food
2. - Heavy consumers of stimulating drinks (\>5 cups of coffee, tea, chocolate or cola drinks per day).
3. - Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol \> 40 gr/day for men or 24 gr/day for women.
4. - Intake of any medication within 14 days prior to taking the study treatment (except for use of paracetamol short-term symptomatic treatments, according to the investigator criteria), or intake of over-the-counter products (including natural food supplements, vitamins and medicinal plants products) within 7 days prior taking the study treatment.
5. - Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
6. - Positive results for abuse drugs in urine test or ethanol in breath test (Day-1).
7. - Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
8. - Females with positive results from the pregnancy test or breast-feeding.
9. - Smoking within 6 months prior to the study treatment phase (Period 1, Day -1). Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment.
10. - Mentally or legally incapacitated at screening.
11. - Unwillingness or inability to follow the procedures outlined in the protocol.
12. - Volunteers who have difficulties in understanding the language in which the volunteer information is given.
13. - Any condition that, in the opinion of the investigator, may jeopardise the patient's well-being or the trial conduct according to the protocol.

Primary outcomes:
measure: Vital signs - blood pressure
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Vital signs - Heart Rate
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Vital signs - Respiratory Rate
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Vital signs - temperature
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: ECG - Ventricular Rate (HR)
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: ECG - PR interval
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: ECG - QRS interval
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: ECG - QT interval
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: ECG - QTc interval
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentration of Haematocrit as L/L
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses - Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Laboratory analyses
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
measure: Incidence of adverse events
timeFrame: from baseline (pre-dose) to 24 hours after treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institut de Recerca Sant Pau
name: Pol Molina, PharmaD
role: PRINCIPAL_INVESTIGATOR
References: