- PharmaResearch has received U.S. FDA clearance for its Investigational New Drug (IND) application to begin a Phase 1 clinical trial of PRD-101, a nano-based anticancer drug candidate.
- CDMO and CRO Ardena supported the programme by developing a clinical-ready drug product and preparing the IND submission package.
PharmaResearch, headquartered in Seongnam, South Korea, has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of PRD-101, a nano-based anticancer drug candidate. The authorization allows the company to advance the programme into first-in-human clinical evaluation.
The IND clearance follows collaboration with Ardena, which operates as both a contract development and manufacturing organisation (CDMO) and a bioanalytical contract research organisation (CRO). Ardena supported PharmaResearch in translating the nano-based formulation into a clinical-ready drug product and preparing the IND submission package.
According to the companies, the work involved formulation and process development to prepare the drug candidate for early-stage clinical testing. The Phase 1 trial will assess safety, tolerability, and pharmacokinetics of PRD-101.
“Receiving FDA IND clearance is an important milestone for PRD-101 and supports our plans to initiate a Phase 1 clinical trial.”
Yujin Jung, Head of Global Strategy at PharmaResearch
Ardena said the project required specialised capabilities in nanomedicine development and contract manufacturing to support the programme’s transition from development to clinical evaluation. The collaboration will continue as PRD-101 progresses through its Phase 1 clinical programme.
