I.V. Selonabant in Healthy Adult Subjects

NCT07211607 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AN-IV-25-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

• Number of Participants with Adverse Events

  28 days

• Number of Participants with Clinically Significant Laboratory Test Results

  28 days

• Number of Participants with Clinically Significant Vital Signs Values

  28 days

• Number of Participants with Clinically Significant Abnormal ECG Findings

  28 days

• Number of Participants with Clinically Significant Abnormal Physical Exam Findings

  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

  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.

  28 days

• Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration

  28 days

• Terminal Elimination Phase Half-life (T1/2)

  28 days

• Maximum Observed Concentration (Cmax)

  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).

  28 days

Study Arms (5)

Experimental Cohort 1

EXPERIMENTAL

Single intravenous dose of 1 mg of selonabant or placebo

Drug: selonabant; Drug: placebo

Experimental Cohort 2

EXPERIMENTAL

Single intravenous dose of 2 mg of selonabant or placebo

Drug: selonabant; Drug: placebo

Experimental Cohort 3

EXPERIMENTAL

Single intravenous dose of 5 mg of selonabant or placebo

Drug: selonabant; Drug: placebo

Experimental Cohort 4

EXPERIMENTAL

Single intravenous dose of 10 mg of selonabant or placebo

Drug: selonabant; Drug: placebo

Experimental Cohort 5

EXPERIMENTAL

Single intravenous dose of 20 mg of selonabant or placebo

Drug: selonabant; Drug: placebo

Interventions

placebo DRUG

Placebo infusion which looks the same as the selonabant infusion

Experimental Cohort 1; Experimental Cohort 2; Experimental Cohort 3; Experimental Cohort 4; Experimental Cohort 5

selonabant DRUG

Intravenous infusion of selonabant

Also known as: ANEB-001

Experimental Cohort 1; Experimental Cohort 2; Experimental Cohort 3; Experimental Cohort 4; Experimental Cohort 5

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Anebulo Pharmaceuticals: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

PPD Austin Clinical Research Unit

Austin, Texas, 78744, United States

Location

Study Officials

• Sean Gilbey, MD

  PPD Austin Clinical Research Unit

  PRINCIPAL INVESTIGATOR

• Rebecca Wood-Horrall, MD

  PPD Austin Clinical Research Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: matching placebo
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single ascending dose

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 8, 2025
• Study Start: September 22, 2025
• Primary Completion: May 6, 2026
• Study Completion: May 6, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)