HealthyPhase 1NCT07652697
ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants
A Phase 1 study testing ABX-002 in people with Healthy, run by Autobahn Therapeutics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABX-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 17 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 and minimum weight of 50 kg at the screening visit
- Medically healthy, as deemed by the PI or designee, with no clinically significant medical history, or clinically significant abnormalities in physical examination, clinical laboratory profiles, and vital signs
- Capable of providing written informed consent, able to understand the nature of the trial and, in the opinion of the PI or designee, able to follow all protocol requirements including the schedule of assessments
Who cannot join
- Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History of any illness that, in the opinion of the PI or designee, might have confounded the results of the study or posed an additional risk to the participant
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
- History of thyroid disease
- History or presence of Clinically significant cataract, glaucoma, severe ocular trauma, inflammatory eye disease, or prior ophthalmic surgical procedures or laser surgery in either eye.
- Clinically significant abnormalities on 12-lead ECG at the screening visit
- Positive urine drug or alcohol results at the screening visit or check-in
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Single Dose Three-Way Crossover Study to Evaluate the Bioequivalence of, and the Effect of Food on, ABX-002 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 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.
- Conditions
- Healthy
- Being tested
- ABX-002
- Keywords
- Healthy Volunteers, Bioequivalence, Elunetirom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-002Drug
ABX-002 was supplied as a solution and solid dose form.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ABC | Experimental | Sequence ABC Receives: Drug: ABX-002 |
| Sequence BCA | Experimental | Sequence BCA Receives: Drug: ABX-002 |
| Sequence CAB | Experimental | Sequence CAB Receives: Drug: ABX-002 |
| Sequence ACB | Experimental | Sequence ACB Receives: Drug: ABX-002 |
| Sequence BAC | Experimental | Sequence BAC Receives: Drug: ABX-002 |
| Sequence CBA | Experimental | Sequence CBA Receives: Drug: ABX-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants.
Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Measured: 8 weeks
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation
Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001
Measured: 8 weeks
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation
Change in Peak Plasma Concentration for ABX-002 and LL-340001
Measured: 8 weeks
Secondary outcomes (4)
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Measured: 8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001
Measured: 8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Change in Peak Plasma Concentration for ABX-002 and LL-340001
Measured: 8 weeks
Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants.
Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start2 Jan 2025
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants received each treatment on one occasion. The treatment sequences participants were randomized to included: ABC, BCA, CAB, ACB, BAC, and CBA.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autobahn Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652697
- Sponsor's protocol ID
- ABX-002-1903
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single Dose Three-Way Crossover Study to Evaluate the Bioequivalence of, and the Effect of Food on, ABX-002 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07652697
- Acronym / sponsor ID
- ABX-002-1903
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Bioequivalence, Elunetirom
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Autobahn Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants received each treatment on one occasion. The treatment sequences participants were randomized to included: ABC, BCA, CAB, ACB, BAC, and CBA.
| Arm | Type | Receives |
|---|---|---|
| Sequence ABC | Experimental | Drug: ABX-002Sequence ABC |
| Sequence BCA | Experimental | Drug: ABX-002Sequence BCA |
| Sequence CAB | Experimental | Drug: ABX-002Sequence CAB |
| Sequence ACB | Experimental | Drug: ABX-002Sequence ACB |
| Sequence BAC | Experimental | Drug: ABX-002Sequence BAC |
| Sequence CBA | Experimental | Drug: ABX-002Sequence CBA |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 and minimum weight of 50 kg at the screening visit
- Medically healthy, as deemed by the PI or designee, with no clinically significant medical history, or clinically significant abnormalities in physical examination, clinical laboratory profiles, and vital signs
- Capable of providing written informed consent, able to understand the nature of the trial and, in the opinion of the PI or designee, able to follow all protocol requirements including the schedule of assessments
Key exclusion criteria (8 listed)
- Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study
- History of any illness that, in the opinion of the PI or designee, might have confounded the results of the study or posed an additional risk to the participant
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
- History of thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX-002ABX-002 was supplied as a solution and solid dose form. | Drug | Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA |
Primary outcome
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants.
Time frame: 8 weeks
Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation
Time frame: 8 weeks
Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation
Time frame: 8 weeks
Change in Peak Plasma Concentration for ABX-002 and LL-340001
4 secondary outcomes
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Time frame: 8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Time frame: 8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Time frame: 8 weeks
Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABX-002 in people with Healthy, run by Autobahn Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants. (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.