Phase I is to assess the safety and pharmacological properties. If it doesn't show significantly serious adverse effects (in healthy volunteers), it will be regarded as a success and phase 2 will likely follow. The additional bonus is pharmacological properties, e.g. interactions: pharmacodynamics (PD: interaction of body with drug) and pharmacokinetics (PK: interaction of drug with nody) that can be assessed for example by various tissue or blood sample tests. So, the aim is not to assess improvement in health, ... but hey, for what i kmow it may even one day become available even on supermarket shelves if it is safe and can do e healthy person's immune system good!
Also as per study done by CDHR employing KLH model, there may not be a need for dose determination following phase I.
.... previously announced in April:
Subject to the relevant ethic and regulatory approvals, the single and multiple ascending dose, placebo-controlled, double-blind, Phase I study will enrol approximately 49 healthy volunteers, with the objective of assessing safety, pharmacokinetics (PK) and pharmacodynamics (PD). The study will implement CHDR’s unique keyhole limpet haemocyanin (KLH) challenge model that allows for the evaluation of immunomodulatory agents’ pharmacological activity at the earliest stages of clinical development.
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- Ann: Regulatory Clearance received for Phase 1 trial of IMP761
Ann: Regulatory Clearance received for Phase 1 trial of IMP761, page-14
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