Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers (DAO-MAX2024)

May 26, 2025 updated by: AB Biotek
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose 1 (42mg) of DAO
Lowest dose of DAO administered in this study
Dietary supplement: Dose 1 (42mg) of DAO
DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study
Other Names:
  • diamino oxidase (DAO)
Placebo Comparator: Placebo tablets
placebo tablets
Dietary supplement: Placebo
Contains the same excipients as the DAO tablets but without the diamino oxidase content
Experimental: Dose 2 (84mg) of DAO
Medium dose of DAO administered in this study
Dietary supplement: Dose 2 (84mg) of DAO
DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study
Experimental: Dose 3 (210mg) of DAO
Highest dose of DAO administered in this study
Dietary supplement: Dose 3 (210mg) of DAO
DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital signs - blood pressure
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)
from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Heart Rate
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Heart rate as bpm (beats per minute)
from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Respiratory Rate
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Respiratory rate as bpm
from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - temperature
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Body temperature as ºC (Celsius degrees)
from baseline (pre-dose) to 24 hours after treatment administration
ECG - Ventricular Rate (HR)
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: Ventricular rate (bpm)
from baseline (pre-dose) to 24 hours after treatment administration
ECG - PR interval
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: PR interval (ms)
from baseline (pre-dose) to 24 hours after treatment administration
ECG - QRS interval
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QRS interval (ms)
from baseline (pre-dose) to 24 hours after treatment administration
ECG - QT interval
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QT interval (ms)
from baseline (pre-dose) to 24 hours after treatment administration
ECG - QTc interval
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QTc interval through Bazett's formula (ms)
from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
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
Time Frame: 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).
from baseline (pre-dose) to 24 hours after treatment administration
Incidence of adverse events
Time Frame: 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.
from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
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
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
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
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
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.
Time Frame: 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.
from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses - Concentration of Haematocrit as L/L
Time Frame: from baseline (pre-dose) to 24 hours after treatment administration
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
Time Frame: 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.
from baseline (pre-dose) to 24 hours after treatment administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AB Biotek

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pol Molina, PharmaD, Institut de Recerca Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAO-MAX2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Safety and tolerability of the treatments will be evaluated by assessing vital signs, laboratory analyses, ECG and incidence of AE.

IPD Sharing Time Frame

According to legislation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings