Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

June 30, 2020

Study Completion Date

August 30, 2020

Conditions
Phenylketonuria
Interventions
DRUG

CDX 6114

CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug.

OTHER

Matching Placebo

The placebo oral dosing solution will also be supplied as an approximately 240 mL oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.

Trial Locations (2)

6009

Linear Clinical Research Ltd, Nedlands

D-41460

Profil Institut für Stoffwechselforschung GmbH, Neuss

All Listed Sponsors
lead

Société des Produits Nestlé (SPN)

INDUSTRY

NCT04085666 - Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU) | Biotech Hunter | Biotech Hunter