A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
Phase of Trial: Phase I
Latest Information Update: 11 Mar 2016
At a glance
- Drugs Rotigotine (Primary)
- Indications Parkinson's disease
- Focus Pharmacokinetics
- Acronyms 03003MAD
- Sponsors Luye Pharma Group
- 11 Mar 2016 Data from this and another phase I trial (CTP 700269112) will support a New Drug Application (NDA) via a 505(b)(2) pathway to the US FDA for LY03003.
- 31 Aug 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 18 Jun 2015 Planned End Date changed from 1 May 2015 to 1 Jul 2015 as reported by ClinicalTrials.gov