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

NCT06715163 | Completed

• 1 other identifier: DAO-MAX2024
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Tolerability in Healthy Volunteers

Keywords

safety; tolerability; diamino oxidase; DAO; supplementation

Outcome Measures

Primary Outcomes (18)

• Vital signs - blood pressure

  Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)

  from baseline (pre-dose) to 24 hours after treatment administration

• Vital signs - Heart Rate

  Heart rate as bpm (beats per minute)

  from baseline (pre-dose) to 24 hours after treatment administration

• Vital signs - Respiratory Rate

  Respiratory rate as bpm

  from baseline (pre-dose) to 24 hours after treatment administration

• Vital signs - temperature

  Body temperature as ºC (Celsius degrees)

  from baseline (pre-dose) to 24 hours after treatment administration

• ECG - Ventricular Rate (HR)

  Electrocardiogram: Ventricular rate (bpm)

  from baseline (pre-dose) to 24 hours after treatment administration

• ECG - PR interval

  Electrocardiogram: PR interval (ms)

  from baseline (pre-dose) to 24 hours after treatment administration

• ECG - QRS interval

  Electrocardiogram: QRS interval (ms)

  from baseline (pre-dose) to 24 hours after treatment administration

• ECG - QT interval

  Electrocardiogram: QT interval (ms)

  from baseline (pre-dose) to 24 hours after treatment administration

• ECG - QTc interval

  Electrocardiogram: QTc interval through Bazett's formula (ms)

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

  BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L

  BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L

  BIOCHEMISTRY: Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L.

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.

  BIOCHEMISTRY: Concentrations of Albumin measured as g/L. HAEMATOLOGY: Concentrations of Haemoglobin, CCMH measured as g/L.

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentration of Haematocrit as L/L

  HAEMATOLOGY: Concentration of Haematocrit as L/L

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses - Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L

  HAEMATOLOGY: Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L.

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses

  SEROLOGY: HIV, HBV and HCV measured through ELISA analysis as presence or absence (positive or negative result).

  from baseline (pre-dose) to 24 hours after treatment administration

• Laboratory analyses

  SCREENING of DRUGS of ABUSE in URINE: ethanol, cannabis, amphetamines, cocaine, opiates and benzodiazepines measured as presence or absence (positive or negative result).

  from baseline (pre-dose) to 24 hours after treatment administration

• Incidence of adverse events

  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.

  from baseline (pre-dose) to 24 hours after treatment administration

Study Arms (4)

Dose 1 (42mg) of DAO

EXPERIMENTAL

Lowest dose of DAO administered in this study

Dietary Supplement: Dose 1 (42mg) of DAO

Placebo tablets

PLACEBO COMPARATOR

placebo tablets

Dietary Supplement: Placebo

Dose 2 (84mg) of DAO

EXPERIMENTAL

Medium dose of DAO administered in this study

Dietary Supplement: Dose 2 (84mg) of DAO

Dose 3 (210mg) of DAO

EXPERIMENTAL

Highest dose of DAO administered in this study

Dietary Supplement: Dose 3 (210mg) of DAO

Interventions

Dose 1 (42mg) of DAO DIETARY_SUPPLEMENT

DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study

Also known as: diamino oxidase (DAO)

Dose 1 (42mg) of DAO

Placebo DIETARY_SUPPLEMENT

Contains the same excipients as the DAO tablets but without the diamino oxidase content

Placebo tablets

Dose 2 (84mg) of DAO DIETARY_SUPPLEMENT

DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study

Dose 2 (84mg) of DAO

Dose 3 (210mg) of DAO DIETARY_SUPPLEMENT

DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

Dose 3 (210mg) of DAO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Background of allergy, idiosyncrasy or hypersensitivity to Investigational or any products or food
• \- Heavy consumers of stimulating drinks (\>5 cups of coffee, tea, chocolate or cola drinks per day).
• \- 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.
• \- 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.
• \- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
• \- Positive results for abuse drugs in urine test or ethanol in breath test (Day-1).
• \- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
• \- Females with positive results from the pregnancy test or breast-feeding.
• \- 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.
• \- Mentally or legally incapacitated at screening.
• \- Unwillingness or inability to follow the procedures outlined in the protocol.
• \- Volunteers who have difficulties in understanding the language in which the volunteer information is given.
• \- Any condition that, in the opinion of the investigator, may jeopardise the patient's well-being or the trial conduct according to the protocol.

Sponsors & Collaborators

• AB Biotek: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator

Study Sites (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Study Officials

• Pol Molina, PharmaD

  Institut de Recerca Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 4, 2024
• Study Start: July 8, 2024
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: According to legislation

Locations

ES (1)