In vitro toxicity tests by using human white blood cells

Not Applicable

Registration Number: CTRI/2023/06/054171

Lead Sponsor: Anthem Biosciences Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <= 37Â·5Â°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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The genotoxic potential of test compound will be evaluated by measuring % aberrant cells (in case of chromosomal aberration test) or % micronuclei cells (in case of micronucleus test) observed in test compound treated cultures will be compared with the negative control treated and statistically compared for the significance.Timepoint: Day 0 - Blood withdrawal, hematology (CBC) and culturing <br/ ><br>Day 2 â?? Test item exposure of peripheral blood cultures <br/ ><br>Day 3 â?? Harvesting of cultures and slide preparation for cytotoxicity/ mutagenicity evaluation

Secondary Outcome Measures