A Randomized Double-Blind Placebo Controlled Multiple Cohort Sequential Dose Escalation Phase 1 Clinical Study to evaluate the Safety and Tolerability of HDCD-012435 in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Assessment of safety of investigational product through general physical examination and laboratory investigations.
研究概览
简要总结
This study is planned to be Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Single and Multiple Dose, Sequential Dose Escalation Study. Subjects will be examined for eligibility during screening period after signing the informed consent form within 7 days prior to Baseline. Sufficient number of subjects will be screened for every cohort to enroll 10 subjects in each cohort total 4 cohorts, 40 subjects, to have at least 8 completed subjects in each cohort. Subjects will be enrolled based on study eligibility criteria inclusion and exclusion criteria sequentially. Subjects will be randomized either into active or in the placebo group in each cohort. All the subjects belonging to the same cohort will be given IP active or placebo on the same day. IP administration will start from Cohort 1 and the dosing schedule will be based on available safety & tolerability results of the preceding cohort as applicable. There will be a gap of a maximum of 7 days before administration to the next cohort. Same subject cannot participate in more than one cohort. To assess the safety and tolerability of HDCD-012435 in healthy volunteers.
Study End points are Assessment of safety of Investigational Product through General Physical Examination & Laboratory Investigations. Incidence of adverse events during the study period. Proportion of subjects withdrawing from trial because of adverse events tolerability. Assessment of Gastrointestinal tolerability through Gastrointestinal Symptom Rating Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1.Healthy adult male or female subjects aged between 18- 45 years.
- •2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1).
- •3.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).
- •4.Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
- •5.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.
- •6.Subjects willing to sign informed consent and follow the study procedure.
排除标准
- •1.Subjects 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.
- •(Subject with any chronic medical condition under control to be also excluded).
- •2.Subjects 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).
- •3.Subjects with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures.
- •4.Subjects with known history or present condition of allergic response to the study product or any ingredients in the study product.
- •5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications.
- •6.Pregnant and lactating women (as assessed by UPT & History of Amenorrhea).
- •7.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 8.Known alcohol or any other substance abuse according to DSM-V criteria.
- •Any other reason (physical, psychological or social) that can interfere with the subject’s compliance with the study in the opinion of the Investigator.
结局指标
主要结局
1. Assessment of safety of investigational product through general physical examination and laboratory investigations.
时间窗: Day 1 & Day 7
2.Incidence of adverse events during the study period.
时间窗: Day 1 & Day 7
次要结局
- 1. Assessment of Gastrointestinal tolerability through Gastrointestinal symptom rating scale.(2.Proportion of subjects withdrawing from trial because of adverse events.)
研究者
Dr Madhu S N
TrialGuna Private Limited