At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 90 enrolled
Drug / intervention
SBP-9330 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SBP-9330 (With a Nested Food-Effect Arm) After Oral Administration in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating SBP-9330 and Placebo for Smoking Cessation. Completed, enrolled 90 participants across 1 site.
Detailed Summary
This is a single center, first-in-human, randomized, double-blind, placebo-controlled, Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect cohort.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartJul 2021
Primary CompletionMar 2023
TodayJul 2026
First PostedJul 2, 2021
Enrollment StartJul 20, 2021
Primary CompletionMar 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5 years ago
Interventions
SBP-9330drug
SBP-9330 oral capsules
Placebodrug
Placebo oral capsules