NCT06435507

Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Innovative Molecules GmbH · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up. Twenty-four participants are planned to be enrolled in the trial. Each cohort may be expanded by up to 6 additional volunteers, resulting in a maximum of 48 participants possibly enrolled in the trial. Ninety-six volunteers may need to be screened to include 48 volunteers.

Conditions

• Herpes Simplex Virus

Interventions

Type	Name	Description
DRUG	IM-250 (50 mg)	Single dose
DRUG	IM-250 (100 mg)	Single dose
DRUG	IM-250 (200 mg)	Single dose
DRUG	IM-250 (400 mg)	Single dose

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-01-30
• Completion: 2024-05-28
• First posted: 2024-05-30
• Last updated: 2024-10-24

Locations

1 site across 1 country: Germany