Results from a first-in-human study of dersimelagon, an investigational oral selective MC1R agonist.

ABSTRACT:

Purpose

To describe outcomes from the first-in-human study of dersimelagon, an investigational oral selective MC1R agonist, under development for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP).

Methods

In this double-blind, placebo-controlled phase 1 study, the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of dersimelagon in healthy participants were evaluated.

Results

Dersimelagon was generally well tolerated in healthy participants, with the most common TEAEs being lentigo (52.8%) and skin hyperpigmentation (50.0%) after multiple doses. Systemic exposure to dersimelagon in plasma (based on AUC_0-∞ and C_max) increased in a slightly more than dose-pr

SUBMITTER: Ogasawara A 

PROVIDER: S-EPMC10229459 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature