A Prospective, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Multiple- Arm, Parallel Study to evaluate the safety, tolerability, and pharmacokinetics of RNM24 in healthy adult participants
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1) To assess NAD+ Values in blood
研究概览
简要总结
This study is to assess the safety and tolerability of IP as a dietary supplement for human consumption. The current study aims to comprehensively evaluate its potential effects on pharmacokinetics, physical performance, biological age and overall quality of life. These findings will expand our understanding of IP’s therapeutic potential and guide its future clinical applications in anti-aging interventions.
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
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult healthy male/females aged 40 to 65 years.
- •Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m
- •Participants who are willing to provide written Informed Consent for participating in the study
- •Participants who are able to follow verbal and written study directions.
- •Participants must be able to maintain consistent diet and lifestyle habits throughout the study.
- •Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.
- •Participants willing to administer assigned dietary supplements for 3 months.
排除标准
- •Participants on current use of prescription or over-the-counter nicotinic acid.
- •Participants using any statin drugs.
- •Participants having used any tobacco product or used a recreational drug in the past 6 months.
- •Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator.
- •Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease.
- •Participants with history of drug or alcohol abuse.
结局指标
主要结局
1) To assess NAD+ Values in blood
时间窗: Baseline to end of study.
2) Assessment of Biological Age
时间窗: Baseline to end of study.
3) Physical Performance is assessed by endurance test measured on six minutes walking test
时间窗: Baseline to end of study.
4) Change in BMI
时间窗: Baseline to end of study.
5) Quality of Life Assessment will be done using SF-36 Questionnaire
时间窗: Baseline to end of study.
次要结局
- 1) Routine clinical laboratory tests: Haematology, Biochemistry, Lipid Profile, LFT, RFT parameters(2) Safety will be assessed based on number of adverse events)
研究者
Dr Chikkalingaiah Siddegowda
Medstar Specialist Hospital