First-in-Human Clinical Trials
Your First-in-Human Clinical Trials Partner
Altasciences has decades of experience designing, conducting, and reporting on first-in-human (FIH) clinical trials. Small or large molecules, simple or complex trials, we have the expertise, purpose-built Phase 1 facilities, and seamless processes to deliver quality with speed and ease. Benefit from our customized approach, including clinical pharmacology units and integrated, state-of-the-art bioanalytical laboratories in the U.S. and Canada.
- 140 beds with over 190 staff members
- Database of over 45,000 active participants
- 180 beds with over 180 staff members
- Database of over 55,000 active participants
- 265 beds with over 200 staff members
- Database of over 50,000 active participants
Participants in our combined database
An Integrated Solution
At Altasciences, we focus on early phase drug development, so your FIH trial will never compete for resources with larger, later phase trials. We can get your molecules successfully through to clinical proof of concept, providing support for preclinical, clinical, bioanalytical, and manufacturing solutions, to give your program maximum momentum. Beyond proof of concept, you can continue to benefit from our specialized assessments, scaled-up manufacturing, bioanalytical laboratories, and the full array of research support services.
Your FIH project is managed by a cross-functional team, including central program management and centralized scheduling that ensures you hit your critical Phase 1 milestones.
With seamless processes running between the clinic and the bioanalytical lab, co-housing your data enables easy, transparent communication between teams and locations, and strict attention to early phase timelines.
PARALLEL PROCESSING YOUR DRUG DEVELOPMENT PHASES
We expedite the start of your first-in-human trial by initiating certain elements of study start-up while your IND/CTA is undergoing regulatory review. Once the review period is complete and your study is cleared for start from the relevant governmental bodies, your clinic activities at Altasciences can begin immediately. Our complementary and integrated solutions add value and ease to the start of your 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
Study Conduct Specialty
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.
Recruitment and Retention
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.
Dedicated Study Team
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:
- Pulmonary function tests
- CSF collection
- PBMC collection and separation
- Asian/non-Asian ethnobridging
- Renal and hepatic Impairment
Putting Participant Safety First
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
We Deliver on Our Promise
In addition to integrated, comprehensive core FIH trial services, we support your Phase I trials with on-staff, complementary research support expertise (available as full-time equivalent [FTE] or per project) in:
- Protocol development
- Clinical trial monitoring
- Data management
- Medical writing and reporting
The processes and systems we have built to maximize communication and efficiency ensure that your project stays on track, without roadblocks or bottlenecks. Relevant data from each process and stage is stored in a central database so that learnings carry through from service to service — preclinical research to manufacturing, clinical trials, and bioanalysis. Everyone involved in your study has access to all the necessary information in real time.
Imagine the benefits of a dedicated early phase drug development company at your side, handling all the facets of your project from end to end. With Altasciences on your team, you don't have to imagine… we've got your back.
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First In Human Trials (FIH) — FAQs
What are first in human (FIH) trials?
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.
What data are required to support the start of first in human trials?
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.
Are there any complementary trials I may need to consider when planning my FIH trial(s)?
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.
Can Altasciences manufacture the product I need for my first in human trials?
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.
Are you able to recruit the target populations needed for any FIH trial?
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.