Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients

Summary

The primary objective is of this Phase 1 study is to evaluate the safety and tolerability of daily, multiple, oral doses of CDX-6114 when administered to patients with PKU for 14 days. The aim is to check if administration of daily, multiple, oral doses of CDX-6114 to patients with PKU for 14 days shows a clinically acceptable safety and tolerability profile.

Timeline

Start

2020-12-01

Primary completion

2021-12-30

Completion

2021-12-30

Outcome

Outcome not reported

Stopped: “study product composition to move from liquid to solid”

Drugs

Indications