Immune SystemPhase 1ECDA000/02NCT06312423
Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer
A Phase 1 study testing Oligonucleotides, Phosphorothioate in people with Immune System, run by Ministry of Public Health of the Province of La Rioja at 1 site in Argentina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune System
- What is being tested?
- Oligonucleotides, Phosphorothioate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteArgentina
- Study dates
- 23 Feb 2024to 30 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older.
- With the capacity and willingness to comply with the prohibitions and restrictions specified in the protocol.
- 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.
- Capable of reading and understanding all the features of the study.
- Negative PCR (Polymerase Chain reaction) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ) virus;
- Laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the investigational drug.
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- 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).
- Electrocardiogram (ECG) without evidence of acute or chronic significant pathologies.
- Chest X-ray without significant pathological findings.
- Capable of providing their signed and dated informed consent by the study volunteer and the authorized physician.
Who cannot join
- Having participated in a research study within the 60 days prior to the start of the study.
- Having a history of known allergies or a history of anaphylaxis or any other serious adverse reaction to any known drug or excipient.
- History of alcoholism or substance abuse that would prevent compliance with the protocol characteristics.
- Acute infectious disease at the time of enrollment or temperature ≥38.0°C in the 24 hours prior to the scheduled study vaccination.
- Any laboratory abnormality with a severity grade \>1 according to the Common Toxicity Criteria (CTC version 5 - November 2017).
- Body Mass Index (BMI) greater than 35 kg/m2.
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- History of any active chronic disease.
- 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.
- Ongoing pregnancy or planned pregnancy within 3 months after administration of the investigational treatment, or lactation period.
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar
Buenos Aires, 1702
Eduardo Pirotzky, Doctor, 541144696700, epirotzky@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Immune System
- Being tested
- Oligonucleotides, Phosphorothioate
- Keywords
- INMUNOMODULATOR, OLIGONUCLEOTIDE, CYTOKINES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligonucleotides, PhosphorothioateDrug
Also called IMT504
Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 20 mg | Experimental | 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). Receives: Drug: Oligonucleotides, Phosphorothioate |
| Group 2 - 60 mg | Experimental | 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). Receives: Drug: Oligonucleotides, Phosphorothioate |
| Group 3 - 100 mg | Experimental | 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). Receives: Drug: Oligonucleotides, Phosphorothioate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Local and systemic reaction after administration of each dose of the 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
Measured: 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
Number of volunteers overall and in each dose group with investigational drug - associated serious adverse events
Measured: Day 0 to day 28 after last administration of investigational drug
Safety: Variations in the Laboratory results
Number of volunteers overall and in each dose group with variations in laboratory results from baseline to different control
Measured: 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
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)
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Blood samples taken at different times to evaluate:
- Maximum time (tmax): time necessary to reach Cmax (Tmax).
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
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.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Blood samples taken at different times to evaluate:
- Half time (t1/2): defined as the time to reduce the drug concentration by half.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Pharmacokinetics: IMT504 level in Serum
Blood samples taken at different times to evaluate:
- Clearance (CL): Plasma volume of the product that is cleared per unit of time.
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Secondary outcomes (1)
Pharmacodynamics: Interleukin - 35
Blood samples taken at different point of evaluation
Measured: 0, 24 and 48 hours after last administration of investigational drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start23 Feb 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A total of 12 healthy adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. All volunteers will be evaluated at a research site authorized by the Regulatory Authority (ANMAT) to conduct phase 1 studies.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health of the Province of La Rioja
- Sponsor type
- Other government
- Collaborators
- Immunalgia Therapeutics S.A.
- Responsible party
- Sponsor
- Investigators
- Eduardo Pirotzky, Doctor, Principal investigator, Centro Nuestra Señora del PilarAlejandro Montaner, Doctor, Study chair, Immunalgia Therapeutics S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312423
- Sponsor's protocol ID
- ECDA000/02
- Acronym
- ECDA000/02
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06312423
- Acronym / sponsor ID
- ECDA000/02 / ECDA000/02
- Conditions
- Immune System
- Keywords
- INMUNOMODULATOR, OLIGONUCLEOTIDE, CYTOKINES
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ministry of Public Health of the Province of La RiojaOther government
- Collaborators
- Immunalgia Therapeutics S.A.
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 12 healthy adult volunteers of both sexes will be included, who will be progressively incorporated into 3 groups of 4 volunteers each. All volunteers will be evaluated at a research site authorized by the Regulatory Authority (ANMAT) to conduct phase 1 studies.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 20 mg | Experimental | Drug: Oligonucleotides, PhosphorothioateFour 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). |
| Group 2 - 60 mg | Experimental | Drug: Oligonucleotides, PhosphorothioateIf 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). |
| Group 3 - 100 mg | Experimental | Drug: Oligonucleotides, PhosphorothioateIf 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants aged 18 years or older.
- With the capacity and willingness to comply with the prohibitions and restrictions specified in the protocol.
- 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.
- Capable of reading and understanding all the features of the study.
- Negative PCR (Polymerase Chain reaction) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 ) virus;
Key exclusion criteria (10 listed)
- Having participated in a research study within the 60 days prior to the start of the study.
- Having a history of known allergies or a history of anaphylaxis or any other serious adverse reaction to any known drug or excipient.
- History of alcoholism or substance abuse that would prevent compliance with the protocol characteristics.
- Acute infectious disease at the time of enrollment or temperature ≥38.0°C in the 24 hours prior to the scheduled study vaccination.
- Any laboratory abnormality with a severity grade \>1 according to the Common Toxicity Criteria (CTC version 5 - November 2017).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligonucleotides, PhosphorothioateAlso: IMT504Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days | Drug | Group 1 - 20 mg, Group 2 - 60 mg, Group 3 - 100 mg |
Primary outcome
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
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
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
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)
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).
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.
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.
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.
1 secondary outcome
Pharmacodynamics: Interleukin - 35
Time frame: 0, 24 and 48 hours after last administration of investigational drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Pirotzky, Doctor principal investigator
Centro Nuestra Señora del Pilar
Alejandro Montaner, Doctor study chair
Immunalgia Therapeutics S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oligonucleotides, Phosphorothioate in people with Immune System, run by Ministry of Public Health of the Province of La Rioja at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A Lopez, Doctor (5491133016577, ralopez.new@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.