2025-524438-24-00招募中2 期
A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
研究概览
简要总结
To evaluate the safety and tolerability of RJVA-001.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation.
- •Normal calcitonin level as stated in the study protocol.
- •Based on Investigator’s judgement, continuous dose escalation or modification of participant’s current treatment regimen is deemed unacceptable.
- •Participant has deferred insulin therapy.
- •Able to tolerate a once-weekly injectable, once-daily injectable or oral GLP-1RA treatment as evidenced by ongoing treatment and benefit from GLP-1RAs at an efficacious dose.
- •Participants must be willing to abstain from semen/blood donation through 1 year after RJVA-001 injection.
- •Participants must be willing to abstain from alcohol use until completion of the sirolimus taper.
- •Participants must agree not to initiate any new or intensive diet or exercise regimens and/or any new weight loss medications during study participation.
- •Age 35 to 70 years (inclusive).
- •Agree to use appropriate form of contaception for the study duration and for at least 1 year after RJVA-001 infusion.
- •Diagnosis of Type 2 Diabetes.
- •Body mass index as indicated in the study protocol.
- •Fasting plasma glucose and hemoglobin A1c levels as stated in the study protocol.
- •Participants are taking glucagon-like peptide-1 receptor agonists (GLP-1RA) at the maximum tolerated maintenance dose and taking permitted non-insulin glucose lowering agents other than GLP-1RA.
- •Random C-peptide level as stated in the study protocol.
- •Normal thyroid function as defined in the study protocol.
排除标准
- •Diagnosis of Type 1 diabetes or history of ketoacidosis, monogenic diabetes or latent autoimmune diabetes of adults or presence of 1 or more islet cell autoantibodies.
- •History of clinically significant valvular heart disease or severe aortic stenosis.
- •Acute coronary syndrome, stroke or transient ischemic attack as stated in the study protocol.
- •History of dose-limiting persistent adverse side effects from GLP-1RA use.
- •History of severe peripheral vascular disease.
- •History of active malignancy or partial remission from clinically significant malignancy, personal or familial history of medullary thyroid carcinoma as stated in the study protocol.
- •Suspected GI malignancy.
- •History of blood dyscrasias or any disorders causing hemolysis or unstable erythrocytes.
- •History of alcohol or illicit substance abuse as stated in the study protocol.
- •Intake of an investigational drug within 5 half-lives prior to visit 1 or active participation in another clinical trial of an investigational drug or device.
- •Contraindication to systemic steroids or sirolimus.
- •General contraindications to deep or conscious sedation or general anesthesia or high risk as determined by anesthesiologist.
- •Participant is on a weight loss program and is not in the weight maintenance phase, or is on a GLP-1 weight loss medication.
- •Participant has poorly controlled hypertension as defined in the study protocol.
- •Any other clinical or mental condition which, in the opinion of the Investigator, would jeopardize participant’s safety or makes participant a poor candidate for clinical trial participation.
- •History of non-adherence to diabetes treatment in the previous 6 months, as determined by the Investigator.
- •Laboratory and Radiographic Exclusions as stated in the study protocol.
- •Known history of diabetic retinopathy.
- •Active systemic infection or undergoing treatment for recent infection. Does not apply to completely treated infection.
- •Condition(s) requiring systemic immunomodulation or whose immune status makes the participant a poor candidate for clinical trial participation.
- •History of chronic or acute pancreatitis, or elevated fasting triglycerides as stated in the study protocol.
- •Family history of hemochromatosis or cystic fibrosis, as self-reported by the participants will be documented.
- •Contraindications to upper gastrointestinal (GI) endoscopy.
- •Symptomatic cholelithiasis or cholecystitis unless treated by cholecystectomy.
- •Concomitant Medication Exclusions as stated in the study protocol.
- •History of tuberculosis.
- •Immunization with live vaccines within 30 days prior to screening, Visit
- •Known hypersensitivity or allergy to eggs, milk, wheat, or [13C]-labeled Spirulina substrates.
- •Any contraindications to the infusate to be delivered.
- •History of hepatic decompensation/acute liver disease, acute or chronic active hepatitis B or C, alcoholic or autoimmune chronic hepatitis as stated in the study protocol. Known portal hypertension.
- •History of symptomatic heart failure with reduced or preserved ejection fraction.
研究组 & 干预措施
RJVA-001
Test
干预措施: RJVA-001 (Drug)
结局指标
主要结局
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
次要结局
- 1. Change in transgene secretion and glycemic parameters.
- 2. Anti-AAV9 antibody titers, anti-GLP-1 antibody titers and enzyme-linked immunosorbent spot for AAV9 and GLP-1.
- 3. Digital polymerase chain reaction for AAV9 in samples.
- 4. Change from Baseline parameters using continuous glucose monitoring.
研究者
Fractyl Health
Scientific
Fractyl Health Inc.
研究点 (2)
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