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

Ministry of Public Health of the Province of La Rioja

Status and phase: Enrolling; Phase 1

Conditions: Immune System

Treatments: Drug: Oligonucleotides, Phosphorothioate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06312423

ECDA000/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Group 1 - 20 mg

Experimental group

Description:

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).

Treatment:

Drug: Oligonucleotides, Phosphorothioate

Group 2 - 60 mg

Experimental group

Description:

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).

Treatment:

Drug: Oligonucleotides, Phosphorothioate

Group 3 - 100 mg

Experimental group

Description:

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).

Treatment:

Drug: Oligonucleotides, Phosphorothioate