To evaluate the safety and tolerability of Cytokine cocktail therapy in healthy volunteers from healthy donors
- Registration Number
- CTRI/2020/05/025432
- Lead Sponsor
- Health Care Global HCG Cancer CentreInternational stemcell services ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Informed consent understood and signed prior to initiation of any study procedures
2. Healthy male or healthy, non-pregnant, non-lactating female, meeting eligibility criteria 3. Willingness to comply and be available for all protocol procedures including volunteer confinement for about 10 days
4. Age between 18 and 45 years, inclusive on the day of infusion
5. Body Mass Index (BMI) of greater than or equal to 18.5 and lesser than or equal to 30 kg/m2 and Weight greater or equal to 50 kg (110 lbs) and lesser than or equal to 100 kg (220 lbs)
6. In female subject of childbearing potential, a negative urine pregnancy test at screening
7. Females of childbearing potential and males agree to use acceptable contraception for the duration of the study
8. Screening laboratory tests, are in the normal reference range
9. Vital signs are within the acceptable range
10. Negative RT-PCR on testing for COVID-19
11. Has adequate venous access for the infusion and blood collection
12. Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study
13. Available for follow-up for the duration of the study
1. History of a chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
2. Known allergy or expected hypersensitivity in the opinion of the investigator to the studyâ??s cytokine therapy or its components.
3. Chronic use of immunosuppressive agents owing to current autoimmune diseases or who has received immunotherapy within past 30 days.
4. undergone organ transplant in the past 6 months.
5. Clinically significant abnormal electrocardiogram at screening
6. Current or past history of HIV or syphilis infections 20. Pregnant or breastfeeding
7. Treatment with another investigational product within 30 days of dosing, including a drug, vaccine, biologic, device or blood product
8. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
9. Use of H1 antihistamines or beta-blockers within 10 days of dosing.
10. Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
11. Participating or has participated in a therapeutic clinical trial within last 30 days; or have participated in any stem cell research programs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method