A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of HDLD-092320 in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and efficacy Assessment of GI (Gastrointestinal) tolerability through GSRS
研究概览
简要总结
Liver is the second largest organ in human body, which has more than 5,000 separate bodily functions including coagulation, filtering toxins from the body, converting the food into nutrients, regulate hormone levels, fighting infections and illness, regeneration and repair, metabolism of cholesterol, glucose, iron and maintaining their levels and many other functions. Liver disease is the 11th leading cause of death and 15th leading cause of disability-adjusted life-years. The highest impact is on patients aged between 25 to 49 years. Herbal medicines have been widely utilized as effective remedies for the prevention and treatment of multiple health conditions for centuries by almost every known culture.: This Phase I study is designed to establish the safety of HDLD-092320 in healthy human volunteers. The design of this study is based on the principles of the USFDA, EMA & ABPI guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult male or female subjects aged between 18- 45 years.
- •Subjects with normal body mass index (BMI) 18.5-24.9 kg/m2
- •Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests.
- •Subjects who refrain from taking any oral/ topical medication at least 15 days prior and during the study period.
- •(SOS medications to be allowed during the study for any specific medical condition like paracetamol for fever).
- •Women of child-bearing potential using reliable method of contraception within 2 months of screening and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy.
- •Subjects willing to sign informed consent and follow the study procedure.
排除标准
- •Subjects with known clinically significant nervous, endocrinal, cerebrovascular, cardiovascular, respiratory, renal, genitourinary, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator (Subject with any chronic medical condition under control to be also excluded).
- •Subjects with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score more than 1 for any one of the 15 questions to be excluded).
- •Subjects with known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ NAFLD/MAFLD, chronic viral hepatitis like hepatitis B, C).
- •Subjects with known history of acute liver disease like acute hepatitis, within 6 months prior to the study.
- •Subjects with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP.
- •Subjects with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.
- •Subjects with any current infections (bacterial, fungal, viral) at the time of screening as determined by the investigator.
- •Pregnant or lactating women (as assessed by UPT & history of amenorrhea).
- •Male subjects who is not willing to use adequate/ validated contraception and not willing to refrain from donating sperm from first admission to the study until 90 days after the follow-up visit.
- •Subjects who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study.
- •Subjects with history of drug addiction or alcohol abuse within 5 years prior to the study
- •Subjects who undergo strenuous exercise within 7 days prior and during the study.
- •Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
- •Subjects with known history or present condition of allergic response (like urticaria) to the study drug or any ingredients in the investigational product.
结局指标
主要结局
Safety and efficacy Assessment of GI (Gastrointestinal) tolerability through GSRS
时间窗: Day 1 & Day 7
(Gastrointestinal Symptom Rating Scale)
时间窗: Day 1 & Day 7
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Yogananda Reddy R
TrialGuna Private Limited