CTRI/2025/12/099939尚未招募不适用
An open-label, single treatment, single period, bioavailability study to evaluate the safety, tolerability and Pharmacokinetics of DOPS-F02 of LipoSeuticals Inc. USA, following a single intravenous infusion in healthy adult human subjects under fasting condition
LipoSeuticals Inc1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
This is an open-label, single treatment, single period, bioavailability study to evaluate the safety, tolerability and Pharmacokinetics of DOPS-F02 of LipoSeuticals Inc. USA, following a single intravenous infusion in healthy adult human subjects under fasting condition. The primary objective of the study is To evaluate the safety and tolerability of a single intravenous dose of DOPS-F02 and the secondary objective is to characterize the pharmacokinetic profile of the DOPS-F02. The total of 16 subjects will be enrolled into the study. The investigational product will be DOPS-F02 in Saline (0.9% Sodium Chloride, Sterile). The subjects will be housed in the facility 11.00 hours before dosing and 72.00 hours after dosing. The total duration of the study will be at least 05 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are able to understand and provide written informed consent.
- •Subjects must be normal healthy, adult, human beings within 18–55 years of age (both inclusive and weighing at least 50 kgs and not more than 100 kgs (both are inclusive).
- •Having a body mass index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in Kg/height in m
- •Subjects must be of normal health as determined by medical history and physical examination performed within 28 days prior to the IP administration.
- •Have normal ECG, chest X-ray and vital signs [body temperature 95.0ºF (35ºC) to 98.6ºF (37ºC), pulse rate 60 to 100 per minute, systolic blood pressure 100 to 140 mm/Hg, diastolic blood pressure 60 to 90 mm/Hg, respiratory rate 14 to 20 per min and SpO2 levels-95% to 100%].
- •Subjects whose screening laboratory values are within normal limits or laboratory abnormalities considered by the investigator to be of no clinical significance.
- •Subjects who pass the skin prick test prior to check-in.
- •Subjects who are non-smokers and non-alcoholics.
- •Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.
- •If study participant is male volunteer and willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, vasectomized.
- •Subjects should not donate sperm during this time.
- •If study participant is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD).
- •(or) abstinence (or) is postmenopausal for at least 1 year or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study participant).
- •Female study participant should be negative in pregnancy test at screening, check-in and at post study safety assessment.
排除标准
- •History of hypersensitivity (or) idiosyncratic reaction to DOPS-F02 or any other similar products.
- •Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, hematological, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- •Subject who are positive for HIV antibody, HCV, Hepatitis B surface antigen or RPR.
- •Subjects who have consumed alcohol, gutkha, pan masala and tobacco products 48.00 hours prior to check-in of study period and until completion of the study.
- •Subjects who have taken any xanthine containing food or beverages (like tea, coffee, chocolates or cola drinks) 48.00 hours check-in of study period and until completion of the study.
- •Subjects who are pregnant (for females only), unstable asthma or those taking betablockers and/or ACE inhibitors.
- •Subjects who have taken any antihistamines (H1 blockers), tricyclic antidepressants, topical corticosteroids (which may inhibit skin prick test reactions) 72.00 hours prior to check-in of study period.
- •Subjects with history of hypersensitivity reactions to PEG or PEG-Containing Products.
- •Consumption of grapefruit or its products for the past 03 days prior to the study initiation and until completion of the study.
- •Subjects who have taken over the counter (OTC) or enzyme modifying medication or any prescribed medications (including herbal preparation) during the last 07 days of study initiation and until completion of the study.
- •Study participants who have participated in any other clinical investigation using experimental drug or had blood loss of more than 350 mL at single occasion in the past 90 days.
- •Study participants with positive alcohol test and positive urine screen for drugs of abuse at the time of check-in.
- •Study participants with abnormal ranges (clinically significant) in clinical investigations at the time of check-in.
- •Subject who are suffering from diarrhea in the last 24.00 hours, which leads to dehydration.
- •Female subjects who are pregnant (women with childbearing potential) or planning to become pregnant during the study.
研究者
Dr K Srinivas
Actimus Biosciences Private Limited
研究点 (1)
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