First-in-human
First-in-Human & Phase 1 CRO in Australia
iNGENū manages first-in-human and Phase 1 studies end-to-end — fast ~4-week ethics, no IND, established healthy-volunteer units, and the 43.5% R&D rebate — across 150+ indications.
Why sponsors bring first-in-human studies to Australia
End-to-end FIH delivery
Protocol design, ethics submission, healthy-volunteer recruitment, dose escalation and safety monitoring — managed in-house under physician oversight.
Fast, low-cost start
No IND required, ethics in ~4 weeks, and early-phase costs 80–90% below US CROs, before the 43.5% R&D rebate.
FDA-ready data
Studies run to ICH-GCP and 21 CFR Part 11, structured for FDA IND/NDA and EMA submissions.
Frequently asked questions
First-in-human in Australia — FAQs
Can I run a first-in-human study in Australia?
Yes. Australia is a leading first-in-human destination, combining fast ethics timelines, the R&D rebate, and established Phase 1 units. iNGENū manages FIH studies end-to-end — protocol, ethics, healthy-volunteer recruitment, and dose escalation — across 150+ indications.
Why run a first-in-human trial in Australia instead of the US?
Australia needs no IND before dosing, achieves ethics approval in about 4 weeks, costs 80–90% below a US CRO, and returns up to 43.5% of eligible R&D as cash — while producing FDA- and EMA-ready data.
Is Australian first-in-human data accepted by the FDA?
Yes. FIH data generated to ICH-GCP in Australia is routinely accepted in FDA IND/NDA submissions. iNGENū provides FDA regulatory services to bridge the data into US programs.
How fast can a first-in-human study start in Australia?
With no IND and ~4-week ethics approval, FIH studies start materially faster than the US pathway. iNGENū’s in-house regulatory and operations teams compress start-up further.
Plan your first-in-human study
Talk to our physicians about taking your candidate into the clinic in Australia.
Request a proposal