Clinical trial NCT06312423: Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Immune System
Keywords: INMUNOMODULATOR
OLIGONUCLEOTIDE
CYTOKINES
Lead sponsor: Ministry of Public Health of the Province of La Rioja
Sponsor class: OTHER_GOV
Collaborators: name: Immunalgia Therapeutics S.A.
First posted: 2024-03-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 \&gt;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.

Primary outcomes:
measure: Safety: Local and systemic reaction after administration of each dose of the investigational drug
timeFrame: 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
measure: Safety: Serious adverse event
timeFrame: Day 0 to day 28 after last administration of investigational drug
measure: Safety: Variations in the Laboratory results
timeFrame: 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
measure: Pharmacokinetics: IMT504 level in Serum
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
measure: Pharmacokinetics: IMT504 level in Serum
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
measure: Pharmacokinetics: IMT504 level in Serum
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
measure: Pharmacokinetics: IMT504 level in Serum
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
measure: Pharmacokinetics: IMT504 level in Serum
timeFrame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Secondary outcomes:
measure: Pharmacodynamics: Interleukin - 35
timeFrame: 0, 24 and 48 hours after last administration of investigational drug
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CENTRO DE INVESTIGACIÓN PARA ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE FASE1 EN POBLACIÓN ADULTA y DE BIOEQUIVALENCIA. Sanatorio Nuestra Señora del Pilar
Study officials:
affiliation: Centro Nuestra Señora del Pilar
name: Eduardo Pirotzky, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Immunalgia Therapeutics S.A.
name: Alejandro Montaner, Doctor
role: STUDY_CHAIR
References: