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Methods and compositions for clinical evaluation of therapeutic agents

A technology of therapeutic agent and composition, applied in the field of clinical evaluation and composition of therapeutic agent, can solve problems such as non-standardization

Pending Publication Date: 2021-09-17
JANSSEN BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, measurements of immune cell profiles are currently not standardized for use in clinical research

Method used

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  • Methods and compositions for clinical evaluation of therapeutic agents
  • Methods and compositions for clinical evaluation of therapeutic agents
  • Methods and compositions for clinical evaluation of therapeutic agents

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Multilevel analysis of vaccine-induced human immune responses

[0109] To determine the utility of vaccines or other antigenic / metabolic challenges as physiological perturbations that could be used in future Phase 1 or Phase 2 studies in human volunteers, an assessment is performed to confirm the time course and extent of vaccine / antigen-specific responses. This will also identify one or more immune response signatures for the disease of interest. The study will also allow for an assessment of the types of analytical tools that could realistically be considered for future human clinical studies.

[0110] Materials and methods

[0111] This is a phase 0 exploratory single center study in healthy adult volunteers to evaluate the effect of 2 vaccines and 2 antigen challengers on the systemic immune response and local tissue (if applicable). For comparison of baseline cell populations and inflammatory mediator responses, each subject will serve as their own control. ...

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Abstract

Methods and kits are described for clinical evaluation of a therapeutic agent. In particular, an immune perturbation reflecting an immune response signature of a disease is induced in a healthy subject, and a therapeutic agent of interest is clinically evaluated in the healthy subject with the immune perturbation.

Description

technical field [0001] The present disclosure relates to the field of systematic approaches to immune responses and therapeutic effects, and in particular to methods for the clinical evaluation of therapeutic agents in healthy subjects with induced immune perturbations, including immune responses to diseases of interest feature. Background technique [0002] Currently, most first-in-human studies aim to evaluate the safety and pharmacokinetics of new drugs, with less focus on pharmacodynamics and pharmacodynamics. In healthy human volunteers, many disease-specific molecules are not expressed due to the lack of acute or chronic (eg, autoimmune) immune stimulation, and therefore, the effects of drugs targeting these molecules cannot be easily measured. [0003] Vaccines have been incorporated into early clinical studies of therapeutic agents. For example, in a clinical study of vedolizumab (an α4β7 integrin monoclonal antibody), healthy participants received a single intrave...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50
CPCG01N33/5088G01N2500/10G01N2800/52
Inventor E·S·N·拉穆斯-史密斯N·萨宾斯
Owner JANSSEN BIOTECH INC