CTRI/2026/04/107646尚未招募1 期
A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation, Phase 1 Clinical Study to evaluate the Safety & Tolerability of HGTX-072512 in Healthy Adults.
Himalaya Wellness Company (HWC)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月20日最近更新:
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 HGTX-072512, a herbal formulation developed by |
| Himalaya Wellness Company, in healthy adult volunteers. The study follows a |
| randomized, double-blind, placebo-controlled, multiple cohorts, 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 HGTX-072512 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 HGTX-072512 in healthy adults, providing the basis for |
| further clinical development of the formulation for Dyspepsia / Indigestion. |
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 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.
- •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 clinical study within the last 3 months of screening.
- •Healthy adults who are willingly 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.
- •(Participants 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 significant systemic illness or disorder/ or any other gastrointestinal malignancy/bleeding disorder/Gastrectomy/ history of structural disease in upper GIT (Eg: Ulcer, surgery etc).
- •Patients currently taking medications like antacids, anti-emetics, laxatives or any other for the treatment of gastrointestinal disorders.
- •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 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.
- •Patients with known history or present condition of allergic response to any of the ingredients in the investigational product.
研究者
Dr Sridhar Sreenivasan G
TrialGuna Private Limited
研究点 (1)
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