FIH – 24hr IV Infusion; Renal Impaired Subjects
Drug Continuous IV Infusion for 24 hr Multiple cohorts Healthy volunteers split by Gender and Age Mild and moderate Renal impairment patients Strict Study timeline Start Cohort 1 within 3 days of 31-day IND wait complete; Start each successive cohort within 2 weeks of previous cohort end Study outcome All primary and secondary […]
TQT Study : Clinic and Bioanalysis completed within 2 months
Drug Continuous IV Infusion for 24 hr Study Requirements NDA submitted; FDA requested additional TQT study Corporate business target to submit asap Partnered with Clario for holter set up and ECG analysis Study Design 36 subjects 3 period Crossover: Test, Placebo, Control Study outcome Study Completed and submitted to FDA in 114 days […]
Multiple DDI studies with Post-menopausal Women
Drug Oral small-molecule prenylation inhibitor treatment of HepD Multiple studies Healthy volunteers equally split by gender Post menopausal women Subject Recruitment Timely recruitment/enrollment for all studies Study outcome All primary and secondary objectives met; Sponsor planning to move the drug candidate to next stage Study completed within the sponsor target timeline
Comparative BE for Biologics
Drug IV Biosimilar Study Design PD and Immunogenicity assessments Multiple sites in EU and US In-house for few days followed by daily/weekly follow up visits Subject Recruitment Total 390 subjects AXIS as rescue site during Covid-19 peak to recruit up to 50 subjects Study outcome Studies completed within the sponsor target timeline Some recruitment challenges […]
Delivering Clinical Trial Continuity During a Global Crisis
How AXIS Clinicals helped a global CRO recover a stalled biosimilar study during the height of COVID-19 When the pandemic disrupted clinical research worldwide, one multinational biosimilar study was at risk of falling apart. Enrollment had stalled, timelines slipped, and the sponsor’s commitments hung in the balance. AXIS Clinicals stepped in as a rescue site […]
Drug–Drug Interaction Studies:Demonstrating Agility and Recruitment Excellence
How AXIS Clinicals delivered high-quality DDI data through precise execution and rapid recruitment across multiple studies Drug–drug interaction studies are among the most demanding components of early-phase clinical development, requiring tight protocol control, balanced enrollment, and uninterrupted operational execution. For one sponsor developing a tricyclic small molecule for Hepatitis D, timely completion of multiple DDI […]
AXIS Clinicals USA Announces Enhanced Clinical Pharmacology Capabilities
Dilworth, MN – AXIS Clinicals is pleased to announce the expansion of our US clinical site with the addition of 45 hospital beds, offering the flexibility of 225 total beds in four clinical units and one outpatient unit. This addition compliments the original Dilworth facility design which was built to accommodate simultaneous studies of differing […]
AXIS Clinicals Announces ERT Certification.
Dilworth, MN – Axis Clinicals USA announces they have received ERT Certification. The Certification program ensures sites are proficient in collecting the highest quality ECG data. This is done by conducting Phase I QT assessments using ERT’s proprietary Expert Precision QT approach. With Axis Clinicals being ERT certified, we are able to work with biopharmaceutical clients […]
AXIS Continues Clinical Research During COVID-19 Restrictions
Dilworth, MN – Clinical and bioanalytical studies supporting pharmacology projects and multi-site patient trials continue at AXIS. Various projects supporting research to address the Coronavirus pandemic and other critical research for oncology, neurology, women’s health, and other key therapeutic areas are ongoing. We have placed critical polices for safety and sanitization protocols for staff and […]
AXIS Clinicals US Expands Capabilities to Conduct hADME Studies for NDA Filings
DILWORTH, Minn., Dec. 20, 2024—AXIS Clinicals US is pleased to announce the award of a Radioactive Materials License (RAM License) issued from the Minnesota Department of Health which permits the handling of radioactive materials. This license, along with the creation of extensive SOPs and staff training programs has opened the door to performing humanADME (hADME) […]