Trial Profile
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of M5049 Administered Orally in Healthy Participants
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 13 Apr 2022
Price :
$35
*
At a glance
- Drugs Enpatoran (Primary)
- Indications COVID-19 pneumonia; Cutaneous lupus erythematosus; Systemic lupus erythematosus
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors Merck KGaA
- 07 Apr 2022 Results of population pharmacokinetic/pharmacodynamic model-based simulations for selection of dose by using data from this study published in the Clinical Pharmacology and Therapeutics
- 17 Mar 2021 Results of population PK/PD models by using data from this study presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
- 02 Dec 2019 Status changed from recruiting to completed.