A First-in-Human Study of SBP-9330 in Healthy Subjects
NCT04948827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-04-16
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.
Conditions
- Smoking Cessation
Interventions
- DRUG
-
SBP-9330
SBP-9330 oral capsules
- DRUG
-
Placebo oral capsules
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Sanford Burnham Prebys
collaborator OTHER -
University of California, San Diego
collaborator OTHER -
Camino Pharma, LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-20
- Primary Completion
- 2023-03-06
- Completion
- 2023-03-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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