Selonabant for Healthy Subjects

Overseen By Ken Cundy, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Anebulo Pharmaceuticals

Must not be taking: Anti-anxiety, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Drug addiction, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called selonabant to evaluate its safety and how the body processes it. It targets healthy young adults without major health issues. Participants will receive varying doses of the drug or a placebo (a harmless pill with no effect) to help researchers assess the drug’s safety. It suits individuals aged 18 to 25 who live without significant medical conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, except for hormonal birth control, at least 14 days before the study and throughout its duration. Exceptions can be made only if the investigator and sponsor agree.

Is there any evidence suggesting that selonabant is likely to be safe for humans?

Research has shown that selonabant was generally safe in previous studies. Most side effects were mild and short-lived, including nausea and vomiting, particularly at higher doses. Importantly, no serious medical issues occurred. At a 10-mg dose, selonabant was well tolerated, meaning most people experienced no problems taking it. While this suggests good safety, it's important to remember that this trial is in the early stages (Phase 1), which primarily focuses on assessing a treatment's safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Selonabant is unique because it targets the cannabinoid receptor type 1 (CB1), offering a novel approach compared to existing treatments for inflammation-related conditions. Most current therapies focus on general anti-inflammatory effects, but selonabant specifically modulates the endocannabinoid system, potentially reducing inflammation with fewer side effects. Researchers are excited about its precise action and the possibility of offering a more targeted and effective treatment option. Additionally, the intravenous delivery of selonabant could provide rapid onset of action, which is advantageous in acute settings.

What evidence suggests that selonabant could be effective?

Research has shown that selonabant might be a helpful treatment because it can block the effects of THC, the component of cannabis responsible for the "high." One study found that selonabant reduced the feeling of being high by up to 82.8% and increased alertness. The treatment was safe and well-tolerated, even at higher doses. This suggests selonabant could help manage symptoms related to THC intoxication. Although more research is needed, these early results indicate it might be useful for treating conditions involving the effects of cannabis. ^{1 3 4 6 7}

Who Is on the Research Team?

Sean Gilbey, MD

Principal Investigator

PPD Austin Clinical Research Unit

Rebecca Wood-Horrall, MD

Principal Investigator

PPD Austin Clinical Research Unit

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 25 years who are interested in participating in a study to assess the safety of a new drug. There's not much detail on specific eligibility criteria, but typically participants should be free from chronic health conditions and not taking conflicting medications.

Inclusion Criteria

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

I am between 18 and 25 years old.

My BMI is between 18 and 30, and I weigh between 50kg and 110kg.

Exclusion Criteria

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 baseline coagulation test result outside the normal range for the clinical site

The subject has a positive urine drug screen result for drugs of abuse at screening or check-in

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of selonabant or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Selonabant

Trial Overview The trial is testing Selonabant, administered intravenously, against a placebo. It's an early-stage (Phase 1) study focusing on how safe the drug is, how well it's tolerated by subjects, and how it moves through and out of the body over time.

How Is the Trial Designed?

Group I: Experimental Cohort 5 Experimental Treatment 2 Interventions

Single intravenous dose of 20 mg of selonabant or placebo

Group II: Experimental Cohort 4 Experimental Treatment 2 Interventions

Single intravenous dose of 10 mg of selonabant or placebo

Group III: Experimental Cohort 3 Experimental Treatment 2 Interventions

Single intravenous dose of 5 mg of selonabant or placebo

Group IV: Experimental Cohort 2 Experimental Treatment 2 Interventions

Single intravenous dose of 2 mg of selonabant or placebo

Group V: Experimental Cohort 1 Experimental Treatment 2 Interventions

Single intravenous dose of 1 mg of selonabant or placebo

Who Is Running the Clinical Trial?

Anebulo Pharmaceuticals

Lead Sponsor

Trials

2

Recruited

270+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07211607

NCT07211607 | I.V. Selonabant in Healthy Adult Subjects This is a Phase 1, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, and PK of single IV doses ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11993283/

CB1 Receptor Antagonist Selonabant (ANEB‐001) Blocks ... Selonabant largely blocked the acute effects of THC intoxication at oral THC doses of up to 21 mg and was safe and well tolerated.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39898464/

CB1 Receptor Antagonist Selonabant (ANEB-001) Blocks ... Nausea and vomiting occurred more frequently at high selonabant doses; 10-mg selonabant was both well tolerated and efficacious. Present results ...

4. ir.anebulo.com ir.anebulo.com/news-events/press-releases/detail/88/anebulo-pharmaceuticals-announces-first-patients-dosed-in

Press Releases “Anebulo previously evaluated selonabant as an oral treatment in a Phase 2 clinical trial, demonstrating potential for blocking and reversing ...

5. synapse.patsnap.com synapse.patsnap.com/drug/977f9b08c03c403f83bca0b5e534150c

Selonabant - Drug Targets, Indications, Patents Selonabant significantly reduced VAS “Feeling High” (up to −82.8% (95% CI: −91.0%, −67.2%, P < 0.0001) at 30‐mg selonabant) and increased VAS “Alertness” (up to ...

6. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3581

CB1 Receptor Antagonist Selonabant (ANEB‐001) Blocks ... Selonabant was generally safe; most adverse events were mild and transient and no SAEs occurred during the study. Nausea, vomiting, and ...

7. psychiatrictimes.com psychiatrictimes.com/view/first-patients-receive-iv-selonabant-for-acute-cannabinoid-induced-toxicity-in-phase-1-trial

First Patients Receive IV Selonabant for Acute ... The study found that selonabant was generally safe, with no serious adverse events. Adverse effects of nausea, vomiting, and hyperhidrosis ...