Dasabuvir (ABT-333) Clinical Trials

Size	Price	Qty
10mg	USD 127

Clinical Trials

Multiple completed clinical trials sponsored primarily by AbbVie and the Ottawa Hospital Research Institute have evaluated dasabuvir (ABT-333) across Phase 1, Phase 2, and Phase 4 studies in healthy volunteers and patients with chronic hepatitis C. Phase 1 investigations assessed the pharmacokinetics, safety, tolerability, and regional gastrointestinal bioavailability of dasabuvir administered alone or in combination regimens. Furthermore, Phase 2 and Phase 4 studies evaluated therapeutic multi-drug regimens alongside metabolic outcomes, including insulin resistance and lipid profiles, in hepatitis C populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02534870	Completed	Healthy Volunteer	AbbVie	2015-09	Phase 1
NCT02734173	Completed	Hepatitis C	Ottawa Hospital Research Institute\|AbbVie	2015-07	Phase 4
NCT02052349	Completed	Relative Bioavailability	AbbVie	2013-11	Phase 1
NCT01911845	Completed	Chronic Hepatitis C Infection\|Chronic Hepatitis C	AbbVie	2013-04	Phase 2

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

Check the Dasabuvir (ABT-333) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dasabuvir specifically acts as a non-nucleoside inhibitor of the hepatitis C virus NS5B viral RNA-dependent RNA polymerase, blocking viral RNA synthesis and preventing genome replication. By interrupting this essential biochemical process, the compound suppresses viral proliferation, which underlies its therapeutic efficacy in treating chronic hepatitis C 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>).