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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety: Local and systemic reaction after administration of each dose of the investigational drug
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/m
- •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.
研究组 & 干预措施
Group 1 - 20 mg
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).
干预措施: Oligonucleotides, Phosphorothioate (Drug)
Group 2 - 60 mg
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).
干预措施: Oligonucleotides, Phosphorothioate (Drug)
Group 3 - 100 mg
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).
干预措施: Oligonucleotides, Phosphorothioate (Drug)
结局指标
主要结局
Safety: Local and systemic reaction after administration of each dose of the investigational drug
时间窗: 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
Number of volunteers overall and in each dose group with local or systemic reaction, based on evaluation of adverse event recorded during clinical assessments
Safety: Serious adverse event
时间窗: Day 0 to day 28 after last administration of investigational drug
Number of volunteers overall and in each dose group with investigational drug - associated serious adverse events
Safety: Variations in the Laboratory results
时间窗: 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
Number of volunteers overall and in each dose group with variations in laboratory results from baseline to different control
Pharmacokinetics: IMT504 level in Serum
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after last administration of investigational drug
Blood samples taken at different times to evaluate: - Clearance (CL): Plasma volume of the product that is cleared per unit of time.
次要结局
- Pharmacodynamics: Interleukin - 35(0, 24 and 48 hours after last administration of investigational drug)