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NCT06432647 · ClinicalTrials.gov registry record · Phase 1
A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
A Phase 1 study of Healthy Volunteers, sponsored by LeonaBio.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06432647: Completed Phase 1 study of Healthy Volunteers, sponsored by LeonaBio.
NCT06432647 is a Phase 1 study of Healthy Volunteers that has completed, run by LeonaBio. The registered enrollment target is 80 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06432647, a Phase 1 study of Healthy Volunteers, has completed, sponsored by LeonaBio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
Primary Outcome
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ATH-1105
Study Locations (1)
Texas
- Fortrea Clinical Research Unit Inc. - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2024-11-25 |
| Phase | Phase 1 |
What the finished NCT06432647 record still lists
NCT06432647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06432647 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06432647 about?
NCT06432647 is a clinical study titled "A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105". The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
What is the current status of trial NCT06432647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2024-04-24. Estimated completion is 2024-11-25.
What conditions does trial NCT06432647 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06432647?
The interventions under investigation include: Placebo (DRUG), ATH-1105 (DRUG).
Who is sponsoring clinical trial NCT06432647?
This trial is sponsored by LeonaBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06432647 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06432647's enrollment target sits among peer trials
80 86th of 283 higher than 197 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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