Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer (ECDA000/02)

March 12, 2024 updated by: Ministry of Public Health of the Province of La Rioja

Phase 1 Open-label Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an Immunomodulator and Tissue Repair Inducer, in Healthy Volunteers

Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers.

Study Overview

Status

Status

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

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.

Detailed Description

This is a phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers.

A total of 12 adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. The first group will be administered subcutaneously with a single dose of 20 mg of IMT504. The second group will receive 3 doses (20 mg daily for 3 days) and then, if no toxicity is detected, the last group will be administered 5 daily doses of 20 mg/d.

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 (Estimated)

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.
12

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.
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1702
        • Recruiting
        • CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female participants aged 18 years or older.
  2. With the capacity and willingness to comply with the prohibitions and restrictions specified in the protocol.
  3. In female volunteers of childbearing potential, negative pregnancy test at the beginning of the study and commitment to using a contraceptive method from the date of consent signing until 3 months after the study is completed.
  4. Capable of reading and understanding all the features of the study.
  5. Negative PCR (Polymerase Chain reaction) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ) virus;
  6. Laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the investigational drug.
  7. Negative serologies for hepatitis B virus (surface antigens [HBsAg] and antibodies against the core of hepatitis B virus [AntiHBc]), hepatitis C virus (AntiHCV), and human immunodeficiency virus (HIV).
  8. Electrocardiogram (ECG) without evidence of acute or chronic significant pathologies.
  9. Chest X-ray without significant pathological findings.
  10. Capable of providing their signed and dated informed consent by the study volunteer and the authorized physician.

Exclusion Criteria:

  1. Having participated in a research study within the 60 days prior to the start of the study.
  2. Having a history of known allergies or a history of anaphylaxis or any other serious adverse reaction to any known drug or excipient.
  3. History of alcoholism or substance abuse that would prevent compliance with the protocol characteristics.
  4. Acute infectious disease at the time of enrollment or temperature ≥38.0°C in the 24 hours prior to the scheduled study vaccination.
  5. Any laboratory abnormality with a severity grade >1 according to the Common Toxicity Criteria (CTC version 5 - November 2017).
  6. Body Mass Index (BMI) greater than 35 kg/m2.
  7. History of any active chronic disease.
  8. Having received an investigational drug (including drugs related to COVID-19 prophylaxis or sepsis) or used an invasive investigational medical device in the 30 days prior to the start of the study.
  9. Ongoing pregnancy or planned pregnancy within 3 months after administration of the investigational treatment, or lactation period.
  10. Having undergone a surgical procedure requiring hospitalization in the 12 weeks prior to the start of the study, or not fully recovered from the surgery requiring hospitalization, or having a scheduled surgery requiring hospitalization during the expected study participation period or within 3 months after administration of the investigational treatment.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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: Group 1 - 20 mg
Four volunteers will be enrolled (no more than one per day and only after verifying that the preceding volunteer did not show any significant adverse effects) who will be administered the initial dose level (1 x 20 mg of IMT504).
Drug: Oligonucleotides, Phosphorothioate
Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days
Other Names:
  • IMT504
Experimental: Group 2 - 60 mg
If no toxicity is detected and there is good tolerance, another 4 patients will be enrolled (no more than one per day and only after verifying that the preceding one did not show significant adverse effects) who will receive treatment with the next dose level (3 x 20 mg of IMT504, one application per day for 3 consecutive days).
Drug: Oligonucleotides, Phosphorothioate
Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days
Other Names:
  • IMT504
Experimental: Group 3 - 100 mg
If no toxicity is detected and there is good tolerance, another 4 patients will be enrolled (no more than one per day and only after verifying that the preceding one did not show significant adverse effects) who will receive treatment with the next dose level (5 x 20 mg of IMT504, one application per day for 5 consecutive days).
Drug: Oligonucleotides, Phosphorothioate
Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days
Other Names:
  • IMT504

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
Safety: Local and systemic reaction after administration of each dose of the investigational drug
Time Frame: Day 0, day 1 (group 1), days 1, 2, 3 (group 2) and days 1, 2, 3, 4, 5 (group 3), day 7 and day 28 after last administration of investigational drug
Number of volunteers overall and in each dose group with local or systemic reaction, based on evaluation of adverse event recorded during clinical assessments
Day 0, day 1 (group 1), days 1, 2, 3 (group 2) and days 1, 2, 3, 4, 5 (group 3), day 7 and day 28 after last administration of investigational drug
Safety: Serious adverse event
Time Frame: Day 0 to day 28 after last administration of investigational drug
Number of volunteers overall and in each dose group with investigational drug - associated serious adverse events
Day 0 to day 28 after last administration of investigational drug
Safety: Variations in the Laboratory results
Time Frame: Day 0, day 1 (group 1), days 1, 2, 3 (group 2) and days 1, 2, 3, 4, 5 (group 3) and day 7 after last administration of investigational drug
Number of volunteers overall and in each dose group with variations in laboratory results from baseline to different control
Day 0, day 1 (group 1), days 1, 2, 3 (group 2) and days 1, 2, 3, 4, 5 (group 3) and day 7 after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Blood samples taken at different times to evaluate:

- Maximum concentration (Cmax) defined as the maximum plasma concentration of the drug during a dosing interval (peak)
0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Blood samples taken at different times to evaluate:

- Maximum time (tmax): time necessary to reach Cmax (Tmax).
0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Blood samples taken at different times to evaluate:

- Area under the curve (AUC): defined as "total exposure", it is the area under the concentration-time curve, and represents a function of the total amount of bioavailable drug.
0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Blood samples taken at different times to evaluate:

- Half time (t1/2): defined as the time to reduce the drug concentration by half.
0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Blood samples taken at different times to evaluate:

- Clearance (CL): Plasma volume of the product that is cleared per unit of time.
0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamics: Interleukin - 35
Time Frame: 0, 24 and 48 hours after last administration of investigational drug
Blood samples taken at different point of evaluation
0, 24 and 48 hours after last administration of investigational drug

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.
Ministry of Public Health of the Province of La Rioja

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.
Immunalgia Therapeutics S.A.

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: Eduardo Pirotzky, Doctor, Centro Nuestra Señora del Pilar
  • Study Chair: Alejandro Montaner, Doctor, Immunalgia Therapeutics S.A.

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.
February 23, 2024

Primary Completion (Estimated)

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.
August 30, 2024

Study Completion (Estimated)

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.
December 30, 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).
February 28, 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.
March 12, 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.
March 15, 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.
March 15, 2024

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.
March 12, 2024

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.
March 1, 2024

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.
  • ECDA000/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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