Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers

Not Applicable

Completed

• Conditions: Safety and Tolerability in Healthy Volunteers

• Registration Number: NCT06715163
• Lead Sponsor: AB Biotek

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ECG - QT interval	from baseline (pre-dose) to 24 hours after treatment administration	Electrocardiogram: QT interval (ms)
ECG - QTc interval	from baseline (pre-dose) to 24 hours after treatment administration	Electrocardiogram: QTc interval through Bazett's formula (ms)
Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L	from baseline (pre-dose) to 24 hours after treatment administration	BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L
Vital signs - blood pressure	from baseline (pre-dose) to 24 hours after treatment administration	Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)
Vital signs - Heart Rate	from baseline (pre-dose) to 24 hours after treatment administration	Heart rate as bpm (beats per minute)
Vital signs - Respiratory Rate	from baseline (pre-dose) to 24 hours after treatment administration	Respiratory rate as bpm
Vital signs - temperature	from baseline (pre-dose) to 24 hours after treatment administration	Body temperature as ºC (Celsius degrees)
ECG - Ventricular Rate (HR)	from baseline (pre-dose) to 24 hours after treatment administration	Electrocardiogram: Ventricular rate (bpm)
ECG - PR interval	from baseline (pre-dose) to 24 hours after treatment administration	Electrocardiogram: PR interval (ms)
ECG - QRS interval	from baseline (pre-dose) to 24 hours after treatment administration	Electrocardiogram: QRS interval (ms)
Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L	from baseline (pre-dose) to 24 hours after treatment administration	BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L
Laboratory analyses - Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L	from baseline (pre-dose) to 24 hours after treatment administration	BIOCHEMISTRY: Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L.
Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.	from baseline (pre-dose) to 24 hours after treatment administration	BIOCHEMISTRY: Concentrations of Albumin measured as g/L. HAEMATOLOGY: Concentrations of Haemoglobin, CCMH measured as g/L.
Incidence of adverse events	from baseline (pre-dose) to 24 hours after treatment administration	Assessment through the opinion of the Investigator, who should consider if it is contraindicative to continue the volunteer's participation in the study if the volunteer experienced adverse events severe enough.
Laboratory analyses - Concentration of Haematocrit as L/L	from baseline (pre-dose) to 24 hours after treatment administration	HAEMATOLOGY: Concentration of Haematocrit as L/L
Laboratory analyses - Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L	from baseline (pre-dose) to 24 hours after treatment administration	HAEMATOLOGY: Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L.
Laboratory analyses	from baseline (pre-dose) to 24 hours after treatment administration	SCREENING of DRUGS of ABUSE in URINE: ethanol, cannabis, amphetamines, cocaine, opiates and benzodiazepines measured as presence or absence (positive or negative result).

Trial Locations

Locations (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain