Estudio abierto de fase 1 con escalada de dosis para eval... | EligiMed

Estudio abierto de fase 1 con escalada de dosis para evaluar la seguridad y farmacocinética del oligonucleótido fosforotioato IMT504, un inmunomodulador e inductor de reparación tisular, en voluntarios sanos

ReclutandoFase 1ClinicalTrials.gov

ID: NCT06312423Tipo: INTERVENTIONALInicio: 23 de feb de 2024Fin estimado: 30 de dic de 2024

Resumen

Estudio abierto de fase 1 con escalada de dosis para evaluar la seguridad y farmacocinética del oligonucleótido fosforotioato IMT504, un inmunomodulador e inductor de reparación tisular, en voluntarios sanos.

Descripción detallada

Este es un estudio abierto de fase 1 con escalada de dosis para evaluar la seguridad y farmacocinética del oligonucleótido fosforotioato IMT504, un inmunomodulador e inductor de reparación tisular, en voluntarios sanos. Se incluirá un total de 12 voluntarios adultos de ambos sexos, que se incorporarán progresivamente en 3 grupos de 4 voluntarios cada uno. Al primer grupo se le administrará una dosis única de 20 mg de IMT504 por vía subcutánea. El segundo grupo recibirá 3 dosis (20 mg diarios durante 3 días) y, si no se detecta toxicidad, al último grupo se le administrarán 5 dosis diarias de 20 mg/día.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Oligonucleotides, Phosphorothioate

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

Ubicaciones

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

Buenos Aires, Argentina

Eduardo Pirotzky, Doctor · epirotzky@yahoo.com · 541144696700

RECRUITING

Patrocinadores

PrincipalMinistry of Public Health of the Province of La Rioja

ColaboradorImmunalgia Therapeutics S.A.

Contactos

Ricardo A Lopez, Doctor

CONTACT

ralopez.new@gmail.com 5491133016577

Monica E Lombardo, Doctor

CONTACT

mlombardo@nobeltri.com 5491141763599

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