The Phase I Clinical Trial Units for Therapeutics support the design, development, implementation, and conduct of Phase I clinical trials to assess safety, pharmacokinetics, and/or pharmacodynamics of licensed and investigational therapeutic products, including immunomodulatory agents and monoclonal antibodies, against viral (other than HIV), bacterial, parasitic, and fungal pathogens, including NIAID priority bio-defense pathogens and emerging and re-emerging infectious diseases. The Phase I Clinical Trial Units can consider studies in healthy volunteers only. Study types that may be proposed include single and multiple ascending dose, drug/drug interaction, disease challenge, cardiac repolarization, food effect, formulation/route changes and other projects with strong bioanalytical needs.
Main Areas of Focus
- Viral (other than HIV), bacterial, and fungal pathogens, including NIAID priority bio-defense pathogens
- Emerging and re-emerging infectious diseases
- Phase I clinical trial support including design, development, implementation, and conduct of trials
- Bioanalysis of samples
- Assessment of safety, pharmacokinetics, and/or pharmacodynamics of licensed and investigational therapeutic products
Who Can Use This Resource
Concepts may be proposed by DMID staff members, or members of the scientific community after consultation with relevant DMID staff.
Each proposal is judged against evaluation criteria. At each stage, concept proposals are evaluated on a number of factors, including, but not limited to:
- Potential public health impact:
- Provides data to support policy decisions
- Impacts development of a product/potential of the product for licensure
- Addresses a question that will advance public health
- Programmatic relevance:
- Fills gaps in the current portfolio
- Has a feasible overall product development plan
- Tests new technologies or approaches
- Is a hypothesis-generating and hypothesis-testing trial
- Leverages collaboration with external (non-DMID) resources
- Feasibility and readiness:
- Accesses readily available populations
- Utilizes a scientifically and statistically appropriate study design
- Uses available scientific data to support the planned indication/path forward
- Requires status of plans/completion of the manufacturing, pre-clinical, and other activities before the proposed trial can start
Assurance to Requestors
Users are required to enter into a Clinical Trials Agreement, as appropriate, which outlines roles, responsibilities, and expectations, including:
- DMID will sponsor the investigational new drug (IND) application for the study.
- In addition to clinical research sites, DMID will provide safety oversight, clinical monitoring, data management, and regulatory management.
- Study product will be shipped to and stored in DMID’s central repository prior to shipping to the clinical site.
- Users will complete non-clinical efforts and supply study product.
- The protocol must be approved by DMID prior to study initiation.
- All Clinical Site Principal Investigators and collaborators will retain publication rights.
- Both DMID and the User will maintain confidentiality.
- Clinical Research Management Icon Government and Public Health Solutions
- Duke University
- DynPort Vaccine Company