Overview
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.
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.