CompletedPhase 1

I.V. Selonabant in Healthy Adult Subjects

United States40 participantsStarted 2025-09-22

Plain-language 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

Who can participate

Age range18 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants with Adverse Events

Timeframe: 28 days

Number of Participants with Clinically Significant Laboratory Test Results

Timeframe: 28 days

Number of Participants with Clinically Significant Vital Signs Values

Timeframe: 28 days

Number of Participants with Clinically Significant Abnormal ECG Findings

Timeframe: 28 days

Number of Participants with Clinically Significant Abnormal Physical Exam Findings

Timeframe: 28 days

Change from Baseline in Beck Depression Inventory (BDI)

Timeframe: 28 days

Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)

Timeframe: 28 days

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

Timeframe: 28 days

Trial details

NCT IDNCT07211607

SponsorAnebulo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-06

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants with Adverse Events

Timeframe: 28 days

Number of Participants with Clinically Significant Laboratory Test Results

Timeframe: 28 days

Number of Participants with Clinically Significant Vital Signs Values

Timeframe: 28 days

Number of Participants with Clinically Significant Abnormal ECG Findings

Timeframe: 28 days

Number of Participants with Clinically Significant Abnormal Physical Exam Findings

Timeframe: 28 days

Change from Baseline in Beck Depression Inventory (BDI)

Timeframe: 28 days

Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)

Timeframe: 28 days

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

Timeframe: 28 days