Therapeutic Expertise › Phase 1 Healthy Volunteer Studies
Phase 1 Healthy Volunteer Studies
Physician-led first-in-human and clinical pharmacology trials in healthy volunteers — FDA-ready from protocol page one.
Overview
What Phase 1 healthy volunteer studies are — and how iNGENū delivers them.
Phase 1 healthy volunteer studies are the earliest human trials of an investigational medicine, typically conducted in healthy adult participants to characterise safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics before progressing into patient populations. They form the scientific and regulatory foundation for every subsequent phase of development.
iNGENū designs and executes Phase 1 healthy volunteer programmes end-to-end: first-in-human single and multiple ascending dose (SAD/MAD) studies, bioavailability and bioequivalence trials, food effect studies, drug–drug interaction (DDI) trials, thorough QT/QTc studies, and human abuse potential studies. Every protocol is directed by a clinical research physician and built to satisfy 21 CFR 312.120, so the resulting data package is fully acceptable for FDA IND and NDA submissions — regardless of where the study is conducted.
Sponsors running first-in-human studies with iNGENū in Australia benefit from one of the fastest regulatory pathways in the world under the TGA CTN scheme, ICH-GCP-compliant infrastructure, and the R&D Tax Incentive of up to 43.5% on eligible clinical trial expenditure.
Why iNGENū
Elite Phase 1 expertise. Specialist speed. Fixed pricing.
iNGENū delivers the clinical pharmacology depth of the elite US Phase 1 units — with the agility, direct physician access, and cost structure of a focused specialist team.
Physician-led from protocol to CSR
Every Phase 1 healthy volunteer study is directed by a qualified clinical research physician — not reviewed intermittently. Sentinel dosing, dose-escalation decisions, and safety reviews are made by board-certified clinicians in real time.
FDA-ready by design
Protocols, informed consent, monitoring procedures, PK sampling, and regulatory documentation are built to 21 CFR 312.120 from day one. Your ex-US Phase 1 data package is fully acceptable for FDA IND and NDA submissions.
TGA CTN speed & R&D Tax Incentive
First-in-human approvals in as little as four weeks under the TGA CTN scheme, combined with up to 43.5% R&D Tax Incentive offset on eligible expenditure — a materially faster and cheaper path to Phase 1 data.
Fixed milestone pricing
Scoped, priced and agreed before work begins. No hourly billing, no change-order inflation, no surprises. Delivery of Phase 1 studies at 80–90% below US Phase 1 unit costs.
Phase 1 healthy volunteer studies — FAQs
Questions biotech sponsors ask us.
Ready to plan your Phase 1 healthy volunteer study?
Tell us about your compound and we'll assemble the right physician-led team.