A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants
brief summary
This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following single-ascending doses and multiple doses, via subcutaneous (SC) administration.
detailed description
The study consists of 3 sequential parts:
* Part A: Single-ascending doses in healthy volunteers * Part B: Single-ascending doses in participants with Stargardt Disease Type 1 (STGD1) * Part C: Multiple doses in participants with Stargardt Disease Type 1 (STGD1)
official title
A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single-Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-RBP4 Administered Subcutaneously in Healthy Volunteers and Participants With Stargardt Disease Type 1 (STGD1)