ACTRN12621000041853已完成1 期
SYNERGY-1: A Phase 1 first-in-human, randomized, double-blind, placebo-controlled, study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating single and multiple doses of KP104.
Kira Pharmaceuticals0 个研究点目标入组 66 人开始时间: 2021年1月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Is male or female, age 18 to 55 years, inclusive, at Screening
- •2. Weight of > 40 kg and < 120 kg at Screening
- •3. In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at Screening and Check-in
- •4. Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the normal range at the Screening Visit; subjects with Gilbert’s disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.
- •5. Creatinine clearance based on the Cockcroft-Gault equation of equals to 80 ml/min
- •6. Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the EOS visit.
- •7. Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal subjects, a blood sample will also be tested for follicle stimulating hormone to confirm post-menopausal status.
- •8. Males must agree to not donate sperm for 90 days following the last dose of IP
- •9. Must provide evidence of prior vaccination against Neisseria meningitidis, Streptococcus pneumoniae, and Hemophilus influenzae at least 2 weeks prior to their initial dose of IP (subjects receiving vaccination during Screening and less than 2 weeks prior to their initial dose of IP are required to receive treatment with appropriate antibiotic prophylaxis until 2 weeks after vaccination); if unvaccinated and they decline vaccination, must agree to self-administer oral antibiotic prophylaxis for a total of 6 weeks following their last dose of IP
- •10. Able to provide Informed Consent
- •11. Willing and able to comply with this protocol and be available for the entire duration of the study
排除标准
- •1. Any clinically significant underlying illness in the opinion of the Investigator
- •2. Any history or sign of significant chronic active or recurrent infection, or screening laboratory evidence consistent with a significant chronic active or recurrent infection requiring treatment with antibacterials, antivirals, or antifungals
- •3. Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibacterials, antivirals, or antifungals
- •4. History of clinically significant hematologic or bone marrow disease or blood dyscrasias
- •5. History of meningococcal infection
- •6. History of tuberculosis
- •7. History of asplenia (functional or anatomical)
- •8. Prior exposure to KP104
- •9. Known allergy to penicillin antibiotics or history of allergy or contraindication to required prophylactic antibiotic therapy to be used during the study
- •10. Known or suspected complement deficiency during screening
- •11. Positive serology for HBV, HCV or HIV at Screening
- •12. History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Check-in
- •13. Received any type of live attenuated vaccine < 1 month prior to Screening or is planning to receive any such live attenuated vaccine over the course of the study
- •14. Use of any prescription or OTC medications including food supplements and herbal medications (e.g. St. John’s wort), with the exception of contraceptive medications and as needed (prn) paracetamol (not exceeding 2 grams/day) within 7 days prior to IP administration
- •15. History of malignancy, except adequately treated basal cell carcinoma or in situ carcinoma of the uterine cervix
- •16. History of drug allergy or drug hypersensitivity, or intolerance of IV or SC injections
- •17. Smoking greater than 10 cigarettes per week in the 3 months prior to IP administration
- •18. History of excessive bleeding following trauma or medical/dental procedures
- •19. Any female who is pregnant or breastfeeding, or any female who is planning to become pregnant during the study and follow-up period
- •20. Any condition that, in the investigator’s opinion, may compromise study participation, present a safety risk to the subject, or may confound the interpretation of the study results
- •21. A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450 millisecond (msec) for males or > 470 msec for females based on either single or averaged QTcF values of triplicate ECGs obtained over a 3-minute interval (at Screening).
- •22. Currently enrolled in another investigational device or drug study, or less than 30 days have passed since ending another investigational device or drug study
研究者
相似试验
已完成
1 期
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104Paroxysmal Nocturnal HemoglobinuriaNCT05490017Kira Pharmacenticals (US), LLC.80
已完成
1 期
A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose (SAD/MAD) study of ENN0403 in healthy subjectsDiabetic retinopathyonalcoholic steatohepatitis (NASH)Nonalcoholic steatohepatitis (NASH)Inflammatory and Immune System - Other inflammatory or immune system disordersPulmonary fibrosisACTRN12622001067763EnnovaBio Australia Pharmaceuticals Pty Ltd69
已完成
1 期
First-in-human Study of Orally Administered KT-621 in Healthy Adult ParticipantsHealthy Participants StudyNCT06673667Kymera Therapeutics, Inc.118
撤回
不适用
A phase 1, first-in-human, 2-part, randomized, double-blind, placebo controlled, single ascending dose and sequential, open-label, multiple ascending dose study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and participants with autoimmune disease(s)autoimmune hepatitisautoimmune disease(s)1001965410003816AIHNL-OMON51485Parexel Nederland3
已完成
1 期
A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)Ulcerative ColitisNCT05975047Liveome Inc.38