ISRCTN17285423进行中（未招募）1 期
A phase Ib, open-label, randomised, single-centre, multiple-dose-escalation study of the safety, tolerability, pharmacokinetics and pharmacodynamics of CpG ODN D35 after subcutaneous administration in participants with cutaneous leishmaniasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female participants aged between 18 to 50 years old at the time of obtaining the informed consent.
- •2. Body weight =55 kg to = 90 kg, body mass index (BMI) 18 to 30.1 kg/m2. BMI = body weight (kg) / [height (m)]2
- •3. Provision of written informed consent to participate as shown by a signature on the participant information sheet and consent form, after reading the information sheet and consent form, and after having the opportunity to discuss the trial with the Investigator or his/her delegate.
- •4. Confirmed diagnosis of cutaneous leishmaniasis by at least one of the following methods conducted as per standard of care at the clinical centre within 56 days before the first dose administration of the IMP:
- •4.1. Microscopic identification of amastigotes in stained lesion tissue, or
- •4.2. Demonstration of leishmania by polymerase chain reaction (PCR), or
- •4.3. Positive culture for promastigotes.
- •5. CL lesions that satisfy the following criteria:
- •5.1. Number of lesions: = 4,
- •5.2. Lesion size: = 4 cm (longest diameter), and
- •5.3. No mucosal involvement.
- •6. Normal blood pressure (BP): systolic blood pressure (SBP) between =100 and =140 mmHg, diastolic blood pressure (DBP) = 90 mmHg, measured after 10 min rest in a supine position, within 28 days before the first dose administration of the IMP.
- •7. A resting heart rate (HR) between =45 and =90 bpm measured after 10 min rest in a supine position, within 28 days before the first dose administration of the IMP.
- •8. ECG recording after 10 min rest in a supine position without clinically significant abnormality, including a Fridericia’s corrected interval between Q and T waves (QTcF) measure of = 450 msec, within 28 days before the first dose administration of the IMP.
- •9. No clinically significant history of previous allergy/sensitivity to CpG ODN D35 or any of the excipients contained within the IMP(s).
- •10. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP.
- •11. Participants with a negative urinary drug of abuse (DoA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated once at the Investigator’s discretion).
- •12. Participants must be available to complete the study (including all follow-up visits).
- •13. Participants must satisfy an Investigator about their fitness to participate in the study.
- •14. Participants registered with the Colombian Health Insurance System.
排除标准
- •1. Female with a positive highly sensitive blood or urine pregnancy test at screening/admission or who is breastfeeding, or lactating
- •2. Female of childbearing potential who does not agree to follow the contraception requirements defined in the protocol
- •3. Within 8 weeks (56 days) of having received treatment for leishmaniasis (topical or systemic) with any method, which likely in the opinion of the Principal Investigator (PI) could modify the course of the leishmania infection
- •4. Behavioural, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the participant to understand and cooperate with the study protocol
- •5. History of clinically significant cardiovascular, renal, hepatic, neurological (especially seizures), immunological, psychiatric, myopathies, bleeding tendency, respiratory and particularly gastrointestinal (GI) disease, especially peptic ulceration and chronic gastritis, GI bleeding, ulcerative colitis, Crohn’s Disease or Irritable Bowel Syndrome, as judged by the Investigator
- •6. Individual or family history of pre-existing autoimmune or antibody-mediated diseases including (but not limited to): systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, type 1 diabetes mellitus, auto-immune thyroiditis, Basedow syndrome, autoimmune thrombocytopenia; or proteinuria (greater than trace protein on urine dipstick testing)
- •7. History of allergy, hay fever, intolerance or photosensitivity to any drug or have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug
- •8. Participants who are taking, or have taken, any prescribed or over-the-counter (OTC) drug (including non-steroidal anti-inflammatory drugs (NSAID)) in the 28 days or 5 half-lives (whichever is longer) before IMP administration. Administration of up to 3 g of paracetamol per day within 7 days of IMP administration is allowed if not used to treat fever
- •9. Participants who have received any prophylactic vaccine (including COVID-19 vaccine) or immunization within the last 28 days or use of corticosteroids or immunosuppressive drugs within 28 days of IMP administration.
- •10. Participants with febrile illness or infectious illness within 2 weeks of IMP administration
- •11. Participants with positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and or human immunodeficiency virus (HIV) tests results at screening
- •12. Positive antigenic COVID-19 test at admission
- •13. Donation or loss of greater than 500 mL of blood within the previous 3 months prior to IMP administration.
- •14. Major surgery within 12 weeks prior to screening.
- •15. Participants who are known or suspected alcohol users above 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol. Positive alcohol test at screening or admission.
- •16. Participants who smoke more than 5 cigarettes per day on average or consume an equivalent nicotine quantity through nicotine-containing products (including e-cigarettes, nicotine patches or gums).
- •17. Participants unable to abstain from smoking without replacement by nicotine products during the hospitalisation periods.
- •18. Demonstrating excess in caffeine
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