Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer

NCT06312423 | Recruiting Phase 1 DMC

• 1 other identifier: ECDA000/02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune System

Keywords

INMUNOMODULATOR; OLIGONUCLEOTIDE; CYTOKINES

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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)

  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).

  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.

  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.

  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.

  0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug

Secondary Outcomes (1)

• Pharmacodynamics: Interleukin - 35

  0, 24 and 48 hours after last administration of investigational drug

Study Arms (3)

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).

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).

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).

Drug: Oligonucleotides, Phosphorothioate

Interventions

Oligonucleotides, Phosphorothioate DRUG

Group 1: 20 mg/day single dose Group 2: 20 mg/day for 3 days Group 3: 20 mg/day for 5 days

Also known as: IMT504

Group 1 - 20 mg; Group 2 - 60 mg; Group 3 - 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ministry of Public Health of the Province of La Rioja: lead
• Immunalgia Therapeutics S.A.: collaborator

Study Sites (1)

CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar

Buenos Aires, 1702, Argentina

RECRUITING

MeSH Terms

Interventions

Phosphorothioate Oligonucleotides; IMT504

Intervention Hierarchy (Ancestors)

Oligonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Eduardo Pirotzky, Doctor

  Centro Nuestra Señora del Pilar

  PRINCIPAL INVESTIGATOR

• Alejandro Montaner, Doctor

  Immunalgia Therapeutics S.A.

  STUDY CHAIR

Central Study Contacts

Ricardo A Lopez, Doctor

CONTACT

5491133016577; ralopez.new@gmail.com

Monica E Lombardo, Doctor

CONTACT

5491141763599; mlombardo@nobeltri.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 15, 2024
• Study Start: February 23, 2024
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

AR (1)