2024-516368-27-00招募中2 期
The double-blind placebo-controlled clinical trial (Phase 1b/2a) to evaluate safety and efficacy of weekly administration of IM-250 in patients with recurrent genital herpes
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- • Rate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.
研究概览
简要总结
To obtain clinical proof of concept investigating weekly administration of IM-250 in suppressive therapy of genital herpes.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years inclusive at the time of consent.
- •Men or women who agree to comply with any applicable contraceptive requirements of the protocol.
- •Prior history of genital HSV-2, acquired at least 12 months prior to screening according to patient’s report. The laboratory confirmation of HSV-2 infection by positive PCR, or cell culture test, or antibody test. There is no timing requirement for the laboratory confirmation, i.e. it can be performed also at screening.
- •For patients currently on suppressive therapy, medical history of 3-9 recurrences within the 12 months prior to initiation of suppressive therapy as reported by the patient during screening interview. Suppressive therapy must be discontinued upon screening and at least 14 days prior to the study medication administration.
- •For patients not on suppressive therapy, medical history of 3-9 episodes (with genital lesion) within the last 12 months before screening as reported by the patient during screening interview.
- •If applicable, willingness to discontinue systemic or topical antiviral treatment at screening at least 14 days prior study medication administration.
- •An understanding, ability, and willingness to fully comply with study interventions and restrictions.
- •Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related interventions.
排除标准
- •Genital herpes episode presence on Day 1 (applies only at randomization).
- •Clinically relevant abnormality in the ECG, defined as one or more of the following or other finding based on a medical evaluation of the recording: a) Prolonged QTcF > 450 ms in males and > 470 ms in females; b) Family history of long QT syndrome; c) PR (PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation); d) PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third-degree AV block, or AV dissociation; e) e) Persistent or intermittent complete BBB, IBBB, or IVCD with QRS > 110 ms. Patients with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation.
- •Clinically relevant abnormality in vital signs, defined as one or more of the following or other relevant medical evaluation of the measurements: a) Systolic BP < 90 mmHg or > 150 mmHg; b) Diastolic BP < 50 mmHg or > 100 mmHg; c) Body temperature of > 37.7°C (on admission day). Note: Vital signs are measured after 5 minutes rest. Abnormal values may be repeated once at the discretion of Investigator.
- •History of severe allergic or anaphylactic reactions to medications or vaccines.
- •Known allergy / hypersensitivity to additives used in the study drug.
- •Use of another study medication within 30 days prior to receiving the first dose of study medication or enrolment in another drug or vaccine clinical trial.
- •A positive antibody screen for human immunodeficiency virus (HIV), or hepatitis C virus (HCV), or a positive hepatitis B virus surface antigen (HBsAg) test.
- •History of vaccination within 14 days prior to dosing.
- •Pregnancy or lactation.
- •Prior participation in this trial (randomization).
- •Phase 1b part: A positive result in testing for illegal drugs at screening.
- •Medical history or current physical illnesses/medical conditions that constitute an unacceptable risk for study participation in the judgment of the investigator (e.g., clinically significant autoimmune disorder, cancer, active infection, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or put the study outcomes at risk, such as uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled coronary heart disease, uncontrolled psychiatric condition).
- •Prior to randomization:
- •Any relevant intercurrent illness since screening.
- •Receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •History of any form of ocular HSV infection or HSV- related erythema multiforme.
- •History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
- •Any abnormal laboratory value (hematology, biochemistry, serology, urine analysis) of Grade 2 or higher, which is considered as clinically significant by Investigator at screening.
- •Value for ALT and/or AST: ≥ 3 times the upper limit of normal at screening.
- •Value for total bilirubin > upper limit of normal (ULN) x 1.2 at screening, where in case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable.
- •Value of creatinine clearance: < 60 ml/min (Cockcroft-Gault equation) at screening.
结局指标
主要结局
• Rate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.
• Rate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.
次要结局
- • Rate of genital lesions, defined as number of days with genital lesions in all patients of a group during 28 days after the first administration of IM-250 or placebo divided by 28.
- • Rate of genital lesions, defined as number of days with genital lesions in all patients of a group during 56 days after the first administration of IM-250 or placebo divided by 56.
- • HSV quantity, defined as comparison of mean log10 HSV DNA copies in patients receiving different doses of IM-250 or placebo on days that shedding is detected.
- • The rate of subclinical shedding, defined as number of days on which genital swab HSV PCR test was positive in absence of a genital lesion divided by the total number of days without lesions on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.
- Determining the exposure by different doses of IM-250 as defined by: • the area under the curve from 0 to infinity (AUC0-ꚙ), • maximum concentration (Cmax), • plasma concentration at 24 hours (C24h) and 8 d (C8d), • the area under the curve from 0 to 24 hours (AUC0-24), • time to reach Cmax (Tmax), • half-life (t1/2), • apparent clearance (Cl / F), • mean residence time (MRT), • volume of distribution (Vd), • the time above the specified lower target concentration (T>Ctarget).
研究者
Company management
Scientific
Innovative Molecules GmbH
研究点 (1)
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