NCT05648799

Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia)

Multicenter Open Two-stage Study of Pharmacokinetics, Safety and Efficacy of GP30341, 200 mg Capsules (GEROPHARM LLC, Russia) in Healthy Volunteers and Outpatients With Novel Coronavirus Infection 2019 With a High Risk of Adverse Outcome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Geropharm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome

Detailed description

Multicenter open two-stage study of pharmacokinetics, safety and efficacy of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) involving healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome. I stage: An open non-comparative study of pharmacokinetics and safety of GP30341 studied at different dosing regimens with an escalation of the daily dose in healthy volunteers. II stage: Open randomized study efficacy and safety of GP30341, 200 mg capsules with active control - comparison with standard therapy - in patients with COVID-19 infection with a high risk of adverse outcome.

Conditions

• Pharmacokinetics
• Safety Issues
• Efficacy

Interventions

Type	Name	Description
DRUG	GP30341 capsules 200 mg	orall take of capsules twice a day
DRUG	Standard therapy	Standard medicines for treatment of a new coronavirus infection 2019 (COVID-19).

Timeline

• Start date: 2022-03-17
• Primary completion: 2022-05-11
• Completion: 2022-07-20
• First posted: 2022-12-13
• Last updated: 2024-07-22

Locations

5 sites across 1 country: Russia