First-in-Human Clinical Trials

Our clinic-ready, small molecule manufacturing experts quickly formulate your drug product and deliver it to the clinical site, ready for dosing. Seamless integration of processes between the CDMO and the clinic, including shared methods and transparent exchange of data, ensures that your small molecule FIH trial kicks off on time, and meets its milestones throughout your program. If needed, certain types of dosage or formulation changes can be handled on the fly.

Our state-of-the-art bioanalytical labs are equipped for all your small molecule and biologic FIH trial needs. We have a large, dedicated method development team to handle de novo method development or transfer of existing methods, to get your clinical study started without delay.

Combining trial conduct and bioanalysis with Altasciences delivers significant benefits:

• Timed interim sample analysis for dose escalation decisions
• Rapid turnaround of PK/PD analysis between cohorts
• Biomarker development and validation for exploratory or primary endpoints
• On-site flow cytometry
• Centralized scheduling between clinic and lab 
• Single point of contact with a dedicated program manager for streamlined communication

We have conducted more than 400 FIH trials at our clinics since 2010, and are conducting 30 per year across our locations. Adaptive designs that allow for changes based on analysis of human data collected during the trial are easily accommodated by leveraging our integrated clinical conduct, bioanalytical, and manufacturing capabilities.

Our three- to four-week database build time allows for go-live before screening begins, so that data is captured in real time from day one.

Our participant database contains comprehensive profiles of over 400,000 volunteers from healthy normal and patients populations, and we benefit from multilingual recruiters. We also have relationships with nearby hospitals and medical facilities for access to additional patients or special populations. Innovative recruitment strategies, using all available media, deliver full panels (including alternates as needed), to ensure cohorts dose on time, and as full cohorts, for your FIH trial.

We treat your FIH program as our own. Your dedicated cross-functional study team will handle every aspect of your trial, including managing any third-party vendors involved. Our team is focused on your success, scheduling activities so that your safety and bioanalytical data are ready for dose escalation meetings, and all study decisions are data-driven. Leveraging our proprietary scheduling system and custom-designed information sharing platforms, our teams are always aligned around your goals and critical milestones.

Depending on the therapeutic area of your molecule and related regulatory requirements, we offer in-house expertise to conduct targeted evaluations:

• CNS Center of Excellence
  • Driving simulation (10 in-house simulators, 13,000 drives conducted)
  • Human abuse potential and abuse-deterrent formulation expertise
  • Physical dependency
  • Factor 8 analysis
  • Cognitive impairment analysis
  • Pain scales
• Cardiac safety
  • Early and thorough QT analysis
• Additional specialized evaluations including:
  • Ophthalmics
  • Pulmonary function tests
  • Imaging
  • CSF collection
  • PBMC collection and separation
  • Asian/non-Asian ethnobridging
  • Renal and hepatic Impairment

Our safety procedures are rigorous, and our operations and facilities are designed to ensure that participant safety is the primary objective in every trial.

• Feasibility/risk assessment – from receipt of first requirements until study completion
• Investigator assesses subjects daily
• 24/7 Advanced Cardiac Life Support (ACLS) provider coverage on-site
• Basic Cardiac Life Support certification for all clinical staff
• Crash carts on-site
• Scenario-based response training
• Telemetry with pulse oximetry
• Strategically placed panic buttons
• Proximity to major hospitals

The U.S. Food and Drug Administration (FDA) Phase I trial includes the first human exposure to an investigational drug (IND). Phase I or FIH trials are typically not large, usually involving from 20-80 subjects. The objective of a classical first in human trial is to determine the safe dose range for further clinical development.

Prior to starting first in human trials, you will be required to submit preclinical and other safety data to the local regulatory authorities to evaluate, to ensure that your drug product is safe for human testing. In the U.S., the Food and Drug Administration (FDA) is responsible for managing drug approvals, and in Europe the European Medicines Agency (EMA) is the regulating body.

You may want to conduct an early QT study, in order to avoid the need for a more detailed thorough QT trial later in development. Depending on your intended indication and signals from safety data, you may also want to consider studying use in special populations or renal/hepatically impaired individuals, and you may need human abuse potential or cognitive/driving impact assessments.

Our manufacturing and analytical services can provide you with clinical trial materials developed under cGMP conditions, for your preclinical and clinical. First in human trials require clinical grade material, and we have the certified facilities to produce liquid and powder-filled capsules, creams, gels, and a range of other products.

Altasciences has a database of 345,000 participants, with full medical screening profiles to allow for targeted outreach and recruitment efforts. We also have collaborative arrangements with local clinics and hospitals for studies involving patients.