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NCT07652697 · ClinicalTrials.gov registry record · Phase 1
ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants
A Phase 1 study, sponsored by Autobahn Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT07652697: Completed Phase 1 study, sponsored by Autobahn Therapeutics.
NCT07652697 is a Phase 1 study that has completed, run by Autobahn Therapeutics. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07652697, a Phase 1 study, has completed, sponsored by Autobahn Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FDA guidelines for the assessment of BE. This was an open label, randomized, single dose, three-way crossover BE and food-effect study. Therefore, the total number of participants in this study was 18.
Primary Outcome
Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Interventions
- DRUG ABX-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2025-02-17 |
| Phase | Phase 1 |
What the finished NCT07652697 record still lists
NCT07652697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which ABX-002 is the first listed.
NCT07652697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07652697 about?
NCT07652697 is a clinical study titled "ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants". The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FD...
What is the current status of trial NCT07652697?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-01-02. Estimated completion is 2025-02-17.
What interventions are being tested in trial NCT07652697?
The interventions under investigation include: ABX-002 (DRUG).
Who is sponsoring clinical trial NCT07652697?
This trial is sponsored by Autobahn Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07652697's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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