A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety & Tolerability of HLTX-072522 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 is a randomized, double-blind, placebo-controlled, multiple-cohort, sequential dose-escalation, Phase 1 clinical study designed to evaluate the safety and tolerability of HLTX-072522, a proprietary herbal formulation developed by Himalaya Wellness Company, in healthy adult volunteers. A total of 40 participants will be enrolled and distributed into four cohorts, with 10 participants per cohort, randomized in a 7:3 ratio to receive either HLTX-072522 or placebo. Each cohort will receive a different dose regimen for 7 days (±1 day window)and Cohorts will be sequential recuritment. The study will comprehensively assess safety and tolerability through the evaluation of adverse events, vital signs, physical examinations, electrocardiograms (ECG), and clinical laboratory parameters such as hematology, biochemistry, and urinalysis.
Given that HLTX-072522 is an orally administered herbal formulation, monitoring of gastrointestinal (GI) symptoms and parameters are included as a key part of the tolerability assessment. Observations for GI-related effects such as nausea, vomiting, abdominal discomfort, or altered bowel habits will help identify any local or systemic adverse effects associated with digestion and absorption. From an Ayurvedic perspective, maintaining optimal Agni (digestive function) and gut balance is fundamental for ensuring both the safety and systemic harmony of the formulation. This evaluation will help confirm the GI tolerance and overall safety profile of HLTX-072522, supporting its further clinical development.
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
- •Adults who meet all the following criteria will be included in the study.
- •Healthy adult male or female 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 Appendix
- •Healthy adults who refrain from taking any oral and 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 informed consent and follow the study procedure.
排除标准
- •Adults who meet any of the following criteria will be excluded from the study.
- •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 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 known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ DILI/MASLD, chronic viral hepatitis like hepatitis B, C).
- •Patients with known history of acute liver disease like acute hepatitis, within 6 months prior to the study (1)
- •Patients with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP.
- •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.
- •Pregnant as assessed by UPT & history of amenorrhea and lactating women.
- •Women of child-bearing potential who refrain to use adequate contraception throughout the study period.
- •Males who refrain to use adequate contraception throughout the study period and not willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
- •Adults who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study.
- •Adults who undergo strenuous exercise within 7 days prior and during the study.
- •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.
- •Patients with known history or present condition of allergic response to any of the ingredients in the investigational product.
研究者
Dr Rajendra Narayan Sharma
TrialGuna Private Limited