Several completed clinical trials, including Phase 2 and unphased protocols, have evaluated therapeutic interventions targeting influenza, asthma, and human immunodeficiency virus. These studies examined key outcomes such as prophylactic responses in asthmatic subjects and tissue viral suppression dynamics during viral infection. Research efforts were sponsored and conducted by entities including Visterra Inc., the Biomedical Advanced Research and Development Authority, Hvivo, Prep Biopharm Limited, and the University of California, Los Angeles.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02989194 | Completed | Influenza |
Visterra Inc.|Biomedical Advanced Research and Development Authority |
2017-01-06 | Phase 2 |
| NCT03296917 | Completed | Asthma |
Hvivo|Prep Biopharm Limited |
2015-12-11 | Phase 2 |
| NCT02134431 | Completed | Human Immunodeficiency Virus |
University of California Los Angeles |
2014-05 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).