A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety & Tolerability of HCFX-072515 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This Phase 1 clinical study is designed to evaluate the safety and tolerability of HCFX-072515, a herbal formulation developed by Himalaya Wellness Company, in healthy adult volunteers. The study follows a randomized, double-blind, placebo-controlled, multiple cohort, sequential dose escalation design. A total of 40 healthy male and female participants aged between 18 and <45 years will be enrolled and divided into four cohorts of ten participants each (seven receiving HCFX-072515 and three receiving placebo). The investigational product will be administered orally for seven days (with a +1 day window) in escalating doses. The dose escalation will proceed from one cohort to the next only after evaluation of safety and tolerability data from the preceding cohort. The planned dose regimen is as follows: Cohort 1 – one tablet once daily, Cohort 2 – one tablet twice daily, Cohort 3 – two tablets once daily, and Cohort 4 – two tablets twice daily. Safety assessments will include monitoring of adverse events, vital signs, physical and systemic examinations, electrocardiogram, laboratory investigations, and gastrointestinal tolerability using the Gastrointestinal Symptom Rating Scale (GSRS).The study aims to establish the safety profile and gastrointestinal tolerability of HCFX-072515 in healthy adults, providing the basis for further clinical development of the formulation for urinary tract and kidney health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 females aged between 18 to less than 45 years with normal body mass index (BMI) 18.5-24.9 kg/m
- •Healthy adults as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1).
- •Healthy adults 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).
- •Healthy adults who have not participated in any other similar clinical study within the last 3 months of screening.
- •Healthy adults who willingly sign the informed consent and follow the study procedure.
排除标准
- •Patients with known clinically significant cardiovascular, respiratory,cerebrovascular, hepatic, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator.
- •(Patients with any chronic medical condition under control to be also excluded).
- •Patients with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded).
- •Patients with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures.
- •Patients with known history or present condition of allergic response to any of the ingredients in the investigational product.
- •Patients with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.
- •Patients with any current infections (bacterial, fungal, viral) at the time of screening as determined by the investigator.
- •Adults who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study.
- •Pregnant as assessed by UPT & history of amenorrhea and lactating women.
- •Women of child-bearing potential who are refusing to use adequate contraception throughout the study period.
- •Males who are refusing to use adequate contraception throughout the study period and refusing from donating sperm from first admission to the study until 90 days after the study completion.
- •Known alcohol, any other substance abuse or any other reason (physical, psychological, or social) that can interfere with the participant’s compliance to the study in the opinion of the Investigator.
研究者
Dr Ratkal C S
TrialGuna Private Limited