CTRI/2023/06/054171
Not yet recruiting
未知
In vitro genotoxicity tests by chromosomal aberration and/ or micronucleus tests using human peripheral blood lymphocytes, collected from human healthy volunteers.
Anthem Biosciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Anthem Biosciences Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non\-smoking
- •Non\-alcoholic
- •Not undergoing any treatment/ not under medication.
- •Subject should be willing to comply with protocol scheduled study visits or procedures, to the best of the subject and Investigatorâ??s knowledge.
- •Subjects within normal limits of CBC count as judged by the physician
- •Have a baseline body temperature of \<\= 37·5°C and have general good health as established by medical history and physical examination.
- •Participant must be on room oxygen with an oxygen saturation of \>\= 93%.
Exclusion Criteria
- •Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
- •History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the Physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Outcomes
Primary Outcomes
Not specified
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