A Randomized, Placebo controlled, double blinded, parallel groupclinical study to evaluate the efficacy and safety of IAI01 (Kutki) as animmunomodulator in adult and elderly population.

InnAdapt Immune0 个研究点目标入组 60 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1. Willing and able to provide written informed consent prior to performing study procedures.
•2. Adult patients aged more than 45 years with or without co morbidities like hypertension and Diabetes mellitus, who are on regular treatment.

•1. Participants with any active illness or infections including COVID19.
•2. Patient having HIV infection.
•3. Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
•4. Have had cancer.
•5. Have received any of the following within 3 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
•6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
•7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
•8. Immuno-compromised patients on medications.
•9. Patients who are on medication of immuno supressors/steroids/antibody (mAb etc), whether injectables/oral/topical, for their other health condition
•10. Participation in any other clinical trial of an experimental treatment in the past 3 months.
•11. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment

发起方

InnAdapt Immune