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

NCT06435507 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-10-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Innovative Molecules GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-01-30
Completion
2024-05-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435507 on ClinicalTrials.gov