Therapeutic Expertise

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.

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, 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.

What is a Phase 1 healthy volunteer study?

Phase 1 healthy volunteer studies are the first clinical trials of an investigational medicine in humans, typically conducted in healthy adults to characterise safety, tolerability, and pharmacokinetics before progressing into patient populations.

What types of Phase 1 healthy volunteer studies does iNGENū run?

iNGENū designs and delivers 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 — all under ICH-GCP E6(R3) and to 21 CFR 312.120 standards.

Why run Phase 1 healthy volunteer studies in Australia with iNGENū?

The TGA CTN scheme can approve early-phase trials in as little as four weeks, the R&D Tax Incentive provides up to 43.5% offset on eligible expenditure, and iNGENū's physician-led model delivers FDA-ready data at 80–90% below US Phase 1 unit costs.

Is data from iNGENū's Phase 1 studies acceptable to the FDA?

Yes. Every iNGENū Phase 1 protocol, monitoring workflow, data management pipeline and regulatory document is designed to satisfy 21 CFR 312.120, ensuring the resulting data package is fully acceptable for FDA IND and NDA submissions.

How quickly can iNGENū start a Phase 1 healthy volunteer study?

With TGA CTN approval achievable in as little as four weeks and iNGENū's physician-led start-up team, dosing of the first cohort can typically begin within 8–12 weeks of contract execution, depending on protocol complexity and manufacturing readiness.

Ready to plan your Phase 1 healthy volunteer study?

Tell us about your compound and we'll assemble the right physician-led team.

Request a proposal