Trials / Completed
CompletedNCT06536101
The Purpose of the Study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Single-ascending and Multiple-ascending Doses of GIM-407
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Georgiamune Inc · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GIM-407 | GIM-407 oral dose |
| DRUG | Placebo | Matching placebo oral dose |
Timeline
- Start date
- 2024-09-02
- Primary completion
- 2025-04-05
- Completion
- 2025-04-05
- First posted
- 2024-08-02
- Last updated
- 2025-07-10
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT06536101. Inclusion in this directory is not an endorsement.