NL-OMON52788已完成2 期
An Open Label, Phase 1/2a Trial to Evaluate the Efficacy, Safety, and Tolerability of KU002 Given as Intravesical Instillations in Subjects with Interstitial Cystitis (IC)/Bladder Pain Syndrome (BPS)* - Phase 1/2a Evaluation of Safety and Efficacy of KU002 in BPS/IC
Kuste Biopharma0 个研究点目标入组 14 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Be at least 18 years of age.
- •2. Willing to provide written informed consent.
- •3. Willing and able to comply with study requirements and visit schedule.
- •4. Have a diagnosis of IC/BPS for at least 6 weeks prior to screening.
- •5. Have undergone a cystoscopy and have visible signs of Hunner*s lesion (photo
- •documented) within 6 weeks prior to study inclusion. If the cystoscopy was not
- •performed within 6 weeks of study inclusion, a new cystoscopy (incl photo of
- •the Hunner*s lesion) must form part of the screening eligibility procedure.
- •6. Have an average daily pain score (recorded over 3 days) > 4 but <9 on
- •the 11-point Numerical Rating Scale (NRS) in the 3 days prior to inclusion.
- •7. Be ambulatory and able to use the toilet independently.
- •8. Have a body mass index >=19 kg/m2 but <=35 kg/m2.
- •9. Have a pre-dose mean systolic/diastolic blood pressure of <=140/90 mmHg
- •before randomization can occur.
- •10. Must not be pregnant, lactating, or actively trying to become pregnant,
- •Subjects who are premenopausal and of childbearing potential must have a
- •negative pregnancy test at Screening (serum) and at Day 0 (urine) and must use
- •a medically acceptable and effective method of birth control for the duration
- •of the study, which can include:
- •a. Having a male partner who is sterile prior to the female subject*s entry
- •into the study and is the sole sexual partner for that female subject.
- •b. Use of double-barrier methods of contraception; condoms with the use of caps
- •(with spermicide) and intra-uterine devices are acceptable.
- •c. Use of hormonal contraceptives (oral, depots, patches, etc.) with
- •double-barrier methods of contraception as outline above.
- •d. True abstinence: When this is in line with the preferred and usual lifestyle
- •of the subject (period abstinence [eg, calendar, ovulation, symptothermal,
- •post-ovulation methods] and withdrawal are not acceptable methods of
- •contraception).
- •e. Male study participants must use a condom for sexual intercourse from
- •screening until at least 90 days after last dose of study drug, unless they
- •have been surgically sterilized (vasectomy).
排除标准
- •1. Current or recent (30 days prior to screening) change in any pharmacologic
- •agent or invasive procedure (e.g. fulguration) used to treat the IC/BPS
- •condition. Patient is eligible to participate in the study if their treatment
- •for IC/BPS has remained stable for the past month prior to entry.
- •2. Concurrent (at Screening), recent (within 30 days), chronic, or recurrent
- •(>4 per year) urinary tract infections (positive dipstick for urinary tract
- •infection and abnormal microscopic evaluation, signs and symptoms) or
- •unevaluated microhematuria.
- •3. Having a history of previous procedure that affects bladder function (e.g.
- •augmentation, cystoplasty, cystectomy, partial bladder resection, cystolysis
- •4. History of cyclophosphamide or chemical cystitis, urinary tuberculosis,
- •radiation cystitis or history of pelvic irradiation.
- •5. Electrostimulation, biofeedback, or bladder training therapy (behavioral
- •therapy), during the previous month prior to Screening, or the intention to
- •initiate such therapies during the study.
- •6. Postvoid residual (PVR) urine volume >150 mL.
- •7. Diagnosis of dementia.
- •8. Subjects with uncontrolled hypertension.
- •9. Documented history of myocardial infarction, unstable angina, and/or has
- •undergone coronary artery bypass surgery and/or percutaneous transluminal
- •coronary angioplasty in the past year.
- •10. Congestive heart failure (New York Heart Association Class III or IV heart
- •11. Any concurrent condition or any clinically significant abnormality on the
- •Screening physical examination, laboratory tests, electrocardiogram (ECG;
- •including ischemic heart disease), Hepatitis B or C, which, in the opinion of
- •the Investigator, may affect the interpretation of efficacy or safety data, or
- •which otherwise contraindicates participation in a clinical study with KU002.
- •a) Hypersensitivity to KU002 or any of its ingredients.
- •b) History of clinically significant drug hypersensitivity.
- •c) History of urogenital neoplasms or malignancies including bladder, urethra,
- •uterine, cervical or vaginal cancer.
- •d) For men: history of prostate surgery (transurethral resection of the
- •prostate [TUR-P], transurethral resection of tumor, [TUR-T], transurethral
- •incision of the prostate [TUIP], transurethral needle ablation [TUNA]), history
- •of prostate cancer or currently (within 30 days) being treated for chronic
- •bacterial prostatitis.
- •e) Subjects with neuropathology that could affect the lower urinary tract or
- •nerve supply, including but not limited to multiple sclerosis, stroke,
- •Parkinsonism, or spinal cord injury.
- •f) Clinically significant or unstable endocrine, hepatic, renal, immunologic
- •(incl immune suppressive and autoimmune) disease or malignancy other than
- •non-melanomatous skin cancer.
- •12. Severe renal impairment (estimated glomerular filtration rate < 30
- •mL/min/1.73m2).
- •13. Hepatic impairment (Child-Pugh B or greater).
- •14. Use of medications for BPH (eg Tamsulosin, silodosin, alfulozin and
- •finasteride) within a month prior to study entry.
- •15. History of an addiction to drugs or alcohol within the last 2 years prior
- •to Screening as determined by the Investigator.
- •16. Participation in a clinical study within a month prior to Screening, or
- 另有 2 项未显示
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