None listed
Conditions
Interventions
None listed
Sponsors
Anthem Biosciences Pvt Ltd
Eligibility
Inclusion 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 Participant must be on room oxygen with an oxygen saturation of >= 93%.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Day 2 â?? Test item exposure of peripheral blood cultures Day 3 â?? Harvesting of cultures and slide preparation for cytotoxicity/ mutagenicity evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactSrinivas Seekallu
Anthem Biosciences Pvt Ltd
Outcome results
None listed