Healthy VolunteersPhase 1NCT07211607

I.V. Selonabant in Healthy Adult Subjects

A Phase 1 study testing selonabant in people with Healthy Volunteers, run by Anebulo Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Selonabant in Healthy Adult Subjects Aged 18 to 30 Years Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: selonabant
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 22 Sep 2025to 6 May 2026
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 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

The subject is male or female 18 to 30 years of age, inclusive.
The subject has a body mass index of 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg and maximum weight of 110 kg.
The subject has no clinically significant medical history and no clinically significant findings in vital sign measurements, 12-lead ECG results, and physical examination findings at screening that would pose a risk in study participation, as determined by the investigator. The subject has no clinical laboratory test results outside the reference range that remain out of range after up to 2 repeat tests within the screening window.
The female subjects must be surgically sterile (ie, hysterectomy and/or oophorectomy) or agree to use a highly effective method of birth control in addition to a secondary barrier method of contraception during the study and for at least 110 days (90 days plus 5 selonabant half-lives, assuming a half-life of 80 hours) after dosing with study treatment.

Who cannot join

The subject is pregnant or lactating.
The subject has used any prescription (excluding hormonal birth control) or over the counter medications within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
The subject has used any vitamin, mineral, herbal, or dietary supplements within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
The subject has used any cannabis products within 14 days of study drug administration.
The subject uses any anti-anxiety, anti-depressant, anti-psychotic, anti-epileptic, or anti-migraine medication.
The subject has a positive urine drug screen result for drugs of abuse at screening or check-in.

Show all 27Show fewer

The subject has a history of alcohol abuse or drug addiction within the last year
The subject's alcohol urine test at screening or check-in was positive. Alcohol will not be allowed for at least 24 hours before screening or check-in until discharge.
The subject has used nicotine- or tobacco-containing products in the last 3 months. Smoking and nicotine use will not be allowed during the study.
The subject has used any caffeine-containing food or drink (eg, tea, coffee, cola, chocolate) or 'energy' drinks within 24 hours before study admission. Caffeine containing food and drink will not be allowed from at least 24 hours before screening or check-in until discharge.
The subject has received a diagnosis (or tests positive at screening) for hepatitis B or hepatitis C.
The subject has a history of HIV, or tests positive for HIV, or has evidence of active tuberculosis (history and/or radiology findings) at screening.
The subject has a medical history of impaired cardiac function or clinically significant cardiac disease
The subject has an estimated glomerular filtration rate of <90 mL/min/1.73 m2, based on the CKD-EPI equation.
The subject has any abnormal, out-of-range screening laboratory values that remain outside laboratory-defined limits after up to 2 repeat tests within the screening window.
The subject has SBP >130 or <90 mm Hg, and DBP >95 or <50 mm Hg at screening or check-in. If a subject fails to meet SBP and/or DBP criteria, up to 2 repeat measurements, one via automated device and one via manual reading, may be completed after the subject has remained in the seated position for 5 minutes between readings, at the discretion of the investigator. For those subjects who have a repeat blood pressure measurement, the repeat value will be used to determine eligibility.
The subject had a loss of blood or donated blood or blood products >500 mL within 4 months prior to screening or has the intention to donate blood or blood products during the study.
The subject has a baseline coagulation test result outside the normal range for the clinical site.
The subject has a history of arterial or venous thrombosis or a family history of a coagulopathy.
The subject has any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as a history of seizures (excluding febrile convulsions below 3 years of age).
The subject has a current psychiatric disorder (including depression), schizophrenia, bipolar disorders, eating disorders, personality disorders, post-traumatic stress disorders, anxiety disorders (including panic, obsessive-compulsive disorders, and phobias), a history of depression or suicidal ideation, or a history of suicide attempt.
The subject has a current or history of neurological disease, including but not limited to, seizure disorder, cerebrovascular disease, intractable headache syndromes (e.g. intractable migraines, history of eclampsia, cluster headaches), multiple sclerosis, ataxias, and extrapyramidal disorders.
The subject has a positive test for SARS-CoV-2.
The subject has a history of serious hypersensitivity reaction to a known ingredient of selonabant or excipients.
The subject has received study drug (selonabant) in any investigational study or received any other investigational study drug in any other study within 30 days of dosing or 5 half lives, whichever is longer.
The subject has difficult venous access or a history of infusion site reactions, including local tissue reactions, hyperpyrexia, or any related reactions.
The subject has intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study requirements, or in the investigator's assessment would place the subject at an unacceptable risk for study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Austin Clinical Research Unit
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Selonabant in Healthy Adult Subjects Aged 18 to 30 Years

Read the detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, and PK of single IV doses of selonabant in healthy adult participants between 18 and 25 years of age. The study will enroll up to 5 sequential cohorts of 8 subjects (6 active, 2 placebo) for a total of up to 40 subjects. The starting dose of selonabant will be 1 mg and the planned doses for subsequent cohorts are 2, 5, 10, and 20 mg. The study is supported by a collaborative U01 grant from NIDA.

Conditions: Healthy Volunteers
Being tested: selonabant, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

selonabantDrug
Also called ANEB-001
Intravenous infusion of selonabant
placeboDrug
Placebo infusion which looks the same as the selonabant infusion

Study groups in NCT07211607
Study group	Role	What they receive
Experimental Cohort 1	Experimental	Single intravenous dose of 1 mg of selonabant or placebo Receives: Drug: selonabant; Drug: placebo
Experimental Cohort 2	Experimental	Single intravenous dose of 2 mg of selonabant or placebo Receives: Drug: selonabant; Drug: placebo
Experimental Cohort 3	Experimental	Single intravenous dose of 5 mg of selonabant or placebo Receives: Drug: selonabant; Drug: placebo
Experimental Cohort 4	Experimental	Single intravenous dose of 10 mg of selonabant or placebo Receives: Drug: selonabant; Drug: placebo
Experimental Cohort 5	Experimental	Single intravenous dose of 20 mg of selonabant or placebo Receives: Drug: selonabant; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events
Measured: 28 days
Number of Participants with Clinically Significant Laboratory Test Results
Measured: 28 days
Number of Participants with Clinically Significant Vital Signs Values
Measured: 28 days
Number of Participants with Clinically Significant Abnormal ECG Findings
Measured: 28 days
Number of Participants with Clinically Significant Abnormal Physical Exam Findings
Measured: 28 days
Change from Baseline in Beck Depression Inventory (BDI)
The minimum possible Beck Depression Inventory (BDI) score is 0, and the maximum score is 63. This score is determined by summing the ratings from the 21 questions, with each question scoring from 0 to 3, indicating the severity of depressive symptoms over the past two weeks. Lower score means less depression
Measured: 28 days
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) does not have a single minimum or maximum score, as it is not a traditional cumulative-score test. Instead, it uses a series of "yes" or "no" questions to place an individual into distinct categories of risk based on their specific responses. Lower score means less suicidal ideation.
Measured: 28 days
Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration
Measured: 28 days
Terminal Elimination Phase Half-life (T1/2)
Measured: 28 days
Maximum Observed Concentration (Cmax)
Measured: 28 days
Pharmacokinetic Clearance (CL)
Pharmacokinetic clearance (\(CL\)) is a quantitative measure of how efficiently the body removes a drug from the bloodstream. It is defined as the volume of plasma from which a drug is completely and irreversibly removed per unit of time and is typically expressed in units like milliliters per minute (mL/min) or liters per hour (L/h).
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 20256 May 2026

First posted8 Oct 2025
Study start22 Sep 2025
Primary completion6 May 2026
Study completion6 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: single ascending dose
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07211607
Sponsor's protocol ID: AN-IV-25-01
Status last verified: May 2026
First submitted: 29 Sep 2025
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Selonabant in Healthy Adult Subjects Aged 18 to 30 Years
ClinicalTrials.gov ID: NCT07211607
Acronym / sponsor ID: AN-IV-25-01
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Anebulo PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 22 Sep 2025 (actual)
Primary completion: 6 May 2026 (actual)
Study completion: 6 May 2026 (actual)
First posted: 8 Oct 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5
Model description: single ascending dose

Arm	Type	Receives
Experimental Cohort 1	Experimental	Drug: selonabant, Drug: placeboSingle intravenous dose of 1 mg of selonabant or placebo
Experimental Cohort 2	Experimental	Drug: selonabant, Drug: placeboSingle intravenous dose of 2 mg of selonabant or placebo
Experimental Cohort 3	Experimental	Drug: selonabant, Drug: placeboSingle intravenous dose of 5 mg of selonabant or placebo
Experimental Cohort 4	Experimental	Drug: selonabant, Drug: placeboSingle intravenous dose of 10 mg of selonabant or placebo
Experimental Cohort 5	Experimental	Drug: selonabant, Drug: placeboSingle intravenous dose of 20 mg of selonabant or placebo

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

The subject is male or female 18 to 30 years of age, inclusive.
The subject has a body mass index of 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg and maximum weight of 110 kg.
The subject has no clinically significant medical history and no clinically significant findings in vital sign measurements, 12-lead ECG results, and physical examination findings at screening that would pose a risk in study participation, as determined by the investigator. The subject has no clinical laboratory test results outside the reference range that remain out of range after up to 2 repeat tests within the screening window.
The female subjects must be surgically sterile (ie, hysterectomy and/or oophorectomy) or agree to use a highly effective method of birth control in addition to a secondary barrier method of contraception during the study and for at least 110 days (90 days plus 5 selonabant half-lives, assuming a half-life of 80 hours) after dosing with study treatment.

Key exclusion criteria (27 listed)

The subject is pregnant or lactating.
The subject has used any prescription (excluding hormonal birth control) or over the counter medications within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
The subject has used any vitamin, mineral, herbal, or dietary supplements within 14 days or less than 5 half-lives (whichever is longer) of screening and for the entire duration of the study. Exceptions will only be made upon the investigator's decision and discussion with the Sponsor.
The subject has used any cannabis products within 14 days of study drug administration.
The subject uses any anti-anxiety, anti-depressant, anti-psychotic, anti-epileptic, or anti-migraine medication.

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
selonabantAlso: ANEB-001Intravenous infusion of selonabant	Drug	Experimental Cohort 1, Experimental Cohort 2, Experimental Cohort 3, Experimental Cohort 4, Experimental Cohort 5
placeboPlacebo infusion which looks the same as the selonabant infusion	Drug	Experimental Cohort 1, Experimental Cohort 2, Experimental Cohort 3, Experimental Cohort 4, Experimental Cohort 5

Primary outcome

Number of Participants with Adverse Events
Time frame: 28 days
Number of Participants with Clinically Significant Laboratory Test Results
Time frame: 28 days
Number of Participants with Clinically Significant Vital Signs Values
Time frame: 28 days
Number of Participants with Clinically Significant Abnormal ECG Findings
Time frame: 28 days
Number of Participants with Clinically Significant Abnormal Physical Exam Findings
Time frame: 28 days
Change from Baseline in Beck Depression Inventory (BDI)
Time frame: 28 days
The minimum possible Beck Depression Inventory (BDI) score is 0, and the maximum score is 63. This score is determined by summing the ratings from the 21 questions, with each question scoring from 0 to 3, indicating the severity of depressive symptoms over the past two weeks. Lower score means less depression
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 28 days
The Columbia-Suicide Severity Rating Scale (C-SSRS) does not have a single minimum or maximum score, as it is not a traditional cumulative-score test. Instead, it uses a series of "yes" or "no" questions to place an individual into distinct categories of risk based on their specific responses. Lower score means less suicidal ideation.
Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration
Time frame: 28 days
Terminal Elimination Phase Half-life (T1/2)
Time frame: 28 days
Maximum Observed Concentration (Cmax)
Time frame: 28 days
Pharmacokinetic Clearance (CL)
Time frame: 28 days
Pharmacokinetic clearance (\(CL\)) is a quantitative measure of how efficiently the body removes a drug from the bloodstream. It is defined as the volume of plasma from which a drug is completely and irreversibly removed per unit of time and is typically expressed in units like milliliters per minute (mL/min) or liters per hour (L/h).

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 8 May 2026.
Individual participant dataSharing planned: No

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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.

Sean Gilbey, MD principal investigator

PPD Austin Clinical Research Unit

Rebecca Wood-Horrall, MD study chair

PPD Austin Clinical Research Unit

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 selonabant in people with Healthy Volunteers, run by Anebulo Pharmaceuticals 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 27 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 8 May 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?

Number of Participants with Adverse Events (time frame: 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211607.

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 8 May 2026.