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Placebo
A First-in-Human Study of SBP-9330 in Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Camino Pharma, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: 8 days part b: 21 days part c: 21 days
Summary
This trial is testing a new treatment to see if it is safe and to find the right dose. It involves healthy volunteers and uses different methods to give the treatment, including checking how food affects it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a: 8 days part b: 21 days part c: 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: 8 days part b: 21 days part c: 21 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
Pharmacokinetics of SBP-9330: AUC 0-24
Pharmacokinetics of SBP-9330: AUC 0-T
Pharmacokinetics of SBP-9330: AUC 0-∞
+13 moreOther study objectives
Expired Carbon Monoxide (ECO) Level
Minnesota Nicotine Withdrawal Scale (MNWS)
Number of Cigarettes Smoked
+2 moreSide effects data
From 2023 Phase 1 trial • 90 Patients • NCT0494882717%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A5 - Single-Dose (Active; 600 mg)
Part B1 - Multiple-Dose (Active; 150 mg)
Part A - Single Dose - Placebo (Pooled)
A1 Single Dose (Active; 150 mg)
Part A3 - Single-Dose Food-Effect (Active; 225 mg)
Part A2 - Single-Dose (Active; 300 mg)
Part A4 - Single-Dose (Active; 450 mg)
Active Comparator: Part B3 - Multiple-Dose (Active; 225 mg)
Active Comparator: Part B2 - Multiple-Dose (Active; 300 mg)
Part B - Multiple-Dose Placebo (Pooled)
Part C1 - Smoker Phase (Active; 150 mg)
Part C2 - Smoker Phase (Active; 225 mg)
Part C - Smoker Phase Placebo (Pooled)
Trial Design
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C2 - Smoker Phase (Active; 225 mg)Experimental Treatment1 Intervention
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group II: Part C1 - Smoker Phase (Active; 150 mg)Experimental Treatment1 Intervention
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group III: Part B3 - Multiple-Dose Active (300 mg)Experimental Treatment1 Intervention
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group IV: Part B2 - Multiple-Dose Active (225 mg)Experimental Treatment1 Intervention
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group V: Part B1 - Multiple-Dose Active (150 mg)Experimental Treatment1 Intervention
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group VI: Part A5 - Single-Dose (Active; 600 mg)Experimental Treatment1 Intervention
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Group VII: Part A4 - Single-Dose (Active; 450 mg)Experimental Treatment1 Intervention
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Group VIII: Part A3 - Single-Dose Food Effect (Active; 225 mg)Experimental Treatment1 Intervention
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Group IX: Part A2 - Single-Dose (Active; 300 mg)Experimental Treatment1 Intervention
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Group X: Part A1 - Single-Dose (Active; 150 mg )Experimental Treatment1 Intervention
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Group XI: Part C - Smoker Phase (Placebo; pooled)Placebo Group1 Intervention
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group XII: Part B - Multiple-Dose Placebo (pooled)Placebo Group1 Intervention
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Group XIII: Part A - Single-Dose (Placebo; pooled)Placebo Group1 Intervention
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects were randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBP-9330
2021
Completed Phase 1
~90
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,618 Total Patients Enrolled
Camino Pharma, LLCLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,795 Total Patients Enrolled
Sanford Burnham Prebys Medical Discovery InstituteUNKNOWN