First in Human Trials and Beyond
Altus Understands

Integrated Preclinical to Clinical Supply Services

As an experienced team of pharmaceutical developers ourselves, Altus understands first-hand the pressure to get your precious new drug to the clinic quickly and cost-effectively. Whether you have a new drug untested in humans, or an older, well-established molecule for a new indication, the time and cost pressures are the same. Altus can help get you to the clinic quickly, efficiently and with the accurate data you need.
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We understand that supplies of your precious new drug will be tight.

Altus employs proprietary strategies to minimize the amount of drug needed to develop your preclinical and clinical formulations, allowing more drugs for testing. Let Altus help you and your drugs go further!

We understand your non-clinical formulation should also work in the clinic.

Developing a new formulation between preclinical and clinical phases is time consuming and expensive. While lead candidates may differ considerably, Altus will employ strategies to minimize differences in their preclinical formulation, while simultaneously refining and building quality into your product throughout the development process to respect regulations. Altus’s expertise allows you to minimize the need for reformulation prior to First in Human trials.

We understand that First in Human trials are expensive.

Based in Montreal, Quebec, Altus can leverage its unique tax advantages to minimize the cost of your First in Human trials.

Six other ways Altus Drug Development helps you get to the clinic and on to the market quickly

Smart Formulation Development
Altus will design your preclinical formulation with the clinic in mind, building the critical product attributes you will need early into development to ensure fast transition from non-clinical animal studies to clinical trials in humans.
Altus’s product development strategies minimize drug expenditure, providing cost-effective approaches to Phase I dose-escalation studies. Altus’s integrated development plans also ensure a simple transition from Ph I safety studies to Phase II efficacy testing.
Enabling Technologies

Are you dealing with difficult to deliver drugs? Altus enabling technologies can help.

MicroSpheres+: Immediate release, delayed release, extended release and pulsatile release microparticulate formulations for preclinical, first in human and dose ranging studies for single or fixed dose combination drugs with the potential to increase bioavailability.

AmyloFlex ODT: Fast dissolving, fast acting sublingual and buccal tablets using Altus proprietary macroporous AmyloFlex technology

Flexitab Tablets: Breakable extended-release tablets that avoid dose dumping while generating multiple tablets segments for flexible patient titration. Flexitab tablets are ideal for titration sensitive and narrow therapeutic index drugs providing bespoke patient focused dosing for value added 505(b)(2) type drugs. The new labelling opportunities provided by Flexitab via simple pharmacokinetic studies can minimize the potential for substitution and copying.

SmartCelle Micelles: SmartCelle micelles can increase the solubility of BCS class II/IV drugs many thousandfold, allowing small volume, high concentration parenteral delivery. SmartCelle can also increase oral bioavailability of insoluble drugs making non-druggable drugs druggable.

SmartCelle Ocular technology can enhance delivery of insoluble molecules to the eye, allowing pan ocular delivery to the anterior and posterior segments after topical delivery.

Altus Technologies enable NCE delivery and add differentiating features for line extension and Value-Added Medicines. Altus Technologies add value while keeping cost of goods to a minimum.

Patent Protection
Altus Technologies come with the added benefit of the Altus Patent Umbrella, providing NCE and Value-Added Medicines with protection in the market place over and above regulatory exclusivity periods.
Clinical (GMP) Supplies
Whether you need a small batch for your first in human Ph I or PoC trial, or larger amounts for Phase II and Phase III trials, Altus can manufacture and package your clinical supplies for global shipments. See our Clinical Supplies services for more information.
Ph I Study Design and Management
Working with our group of cost-effective clinical Phase I CROs, Altus can work with you to generate quotations, develop protocols, manage supply and provide you with the data you need on time and on budget.
Regulatory Support
Our regulatory experts can manage your North American submissions from pre-IND meeting to submission to guarantee your compliance to regulations.

  Discover More About Formulation Development

FAQs about First in Human Trials
What are First in Human (FIH) Studies?
FIH studies are the first clinical studies that you will perform with your drug to test its safety in humans and maybe get a hint of efficacy. Patients in this step of the testing process are usually healthy volunteers.
Applications of FIH studies

New Chemical Entity (NCE)

When they think of FIH studies, most people think of studies with NCEs that have never been administered to humans before. These molecules are approved by FDA under the 505(b)(1) regulatory pathway, for example. Successful FIH studies will then lead to Phase II dose ranging studies to find the effective doses of the NCE, which are then tested in larger Phase III studies to better understand its safety and efficacy in a bigger population. Phase IV studies, which occur after approval, will continue to generate safety and perhaps efficacy data in the broader patient population.

Value-Added Medicine or new molecular entity (NME)

First in Human studies can also apply to testing of Value-Added Medicines, using a well characterized and established drug, or to NMEs, that is drugs that are used in humans that have never been approved by FDA or other regulator. Examples of such FIH studies are;

  1. Testing a well-established drug in a new therapeutic indication, different from the one it was approved for, or testing that drug for the same indication but delivering it by a different route. Or both!
  2. Performing controlled FIH trials with an NME to generate the safety data needed in a well-controlled setting

Like NCE, successful FIH studies will lead to Phase II and Phase III trials. This type of new drug is usually approved by FDA under the 505(b)(2) regulatory pathway and can gain from 3 – 7 years of market exclusivity.

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