Clinical Trials

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)

Check the TCID product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TCID functions as a selective deubiquitinating enzyme inhibitor that directly targets ubiquitin C-terminal hydrolase L3 with an IC50 of 0.6 μM, exhibiting 125-fold selectivity over ubiquitin C-terminal hydrolase L1. By blocking hydrolase-mediated cleavage of ubiquitin conjugates, TCID disrupts downstream proteasomal protein turnover and cellular homeostasis, mitigating pathological cellular mechanisms implicated in clinical trial conditions such as influenza, asthma, and human immunodeficiency virus infection.

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>).

Note: Technical data last updated: Sep 1, 2026.