NCT07211607

I.V. Selonabant in Healthy Adult Subjects

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Anebulo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
DRUG	selonabant	Intravenous infusion of selonabant
DRUG	placebo	Placebo infusion which looks the same as the selonabant infusion

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-08-25
• Completion: 2026-08-25
• First posted: 2025-10-08
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study