Clinical Trials

Several clinical trials evaluate a diverse array of conditions, including HER2-mutated non-small cell lung cancer, drug-drug interactions, chronic spontaneous urticaria, periodontitis, metabolic syndrome, and surgical transfusion complications. Spanning Phase 1/2 through Phase 4 protocols as well as non-interventional designs, these studies assess targeted antitumor efficacy and interaction dynamics across active recruiting, completed, suspended, and pending statuses. The research is sponsored by academic hospitals, research institutes, and biopharmaceutical entities, including West China Hospital, Anbogen Therapeutics Inc., and the Royal College of Surgeons in Ireland.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06399536 Not yet recruiting
Transfusion Related Complication|Hemodilution
West China Hospital
2024-06-01 Not Applicable
NCT05532696 Recruiting
Advanced Solid Tumor|Non Small Cell Lung Cancer|HER2 Mutations
Anbogen Therapeutics Inc.
2022-09-27 Phase 1|Phase 2
NCT05449249 Completed
Healthy|Periodontitis
Buchinger Wilhelmi Development & Holding GmbH|Buchinger Wilhelmi Clinic|University of Geneva Switzerland|King''s College London|ETH Zurich (Switzerland)
2022-09-01 Not Applicable
NCT06108869 Suspended
Chronic Spontaneous Urticaria
Royal College of Surgeons Ireland
2022-06-01 Not Applicable
NCT04053569 Unknown status
Metabolic Syndrome Protection Against
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
2019-10-01 Not Applicable
NCT04006353 Completed
Drug Interaction
Shanghai Public Health Clinical Center
2019-07-11 Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the 1-Aminobenzotriazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

1-Aminobenzotriazole irreversibly binds to cytochrome P450 (CYP) enzymes and N-acetyltransferase (NAT), which blocks downstream oxidative biotransformation pathways and halts cellular drug metabolism. By suppressing hepatic xenobiotic clearance and altering systemic drug disposition, this enzyme inactivation provides a mechanistic rationale for modulating pharmacokinetics in clinical settings, including the study of drug interactions and advanced solid tumors like non-small cell lung cancer.

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.