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SBP-9330 for Smoking Cessation

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
Awards & highlights

Study Summary

This trial is testing a new drug on humans for the first time. It is comparing the new drug to a fake (placebo) drug, and is testing different doses of the new drug to see what is safe. Some people in the trial will eat before taking the new drug, to see if that affects how it works.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: 8 days part b: 21 days part c: 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: 8 days part b: 21 days part c: 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Pharmacokinetics of SBP-9330: AUC 0-24
Pharmacokinetics of SBP-9330: AUC 0-T
Pharmacokinetics of SBP-9330: AUC 0-∞
+13 more
Other outcome measures
Expired Carbon Monoxide (ECO) Level
Minnesota Nicotine Withdrawal Scale (MNWS)
Number of Cigarettes Smoked
+2 more

Side effects data

From 2023 Phase 1 trial • 90 Patients • NCT04948827
25%
Headache
25%
Nausea
25%
Dizziness
25%
Flatulence
25%
Rhinorrhoea
13%
Vomiting
13%
Cough
13%
Dry throat
13%
Ecchymosis
13%
Pruritus
13%
Rash
13%
Vaginal hemorrhage
13%
Constipation
13%
Abdominal pain
13%
Abdominal distention
13%
Orthostatic heart rate response increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part B1 - Multiple-Dose (Active; 150 mg)
Active Comparator: Part B2 - Multiple-Dose (Active; 300 mg)
Part C1 - Smoker Phase (Active; 150 mg)
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)
Part A5 - Single-Dose (Active; 600 mg)
Active Comparator: Part B3 - Multiple-Dose (Active; 225 mg)
Part A - Single Dose - Placebo (Pooled)
Part B - Multiple-Dose Placebo (Pooled)
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 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.
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 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.
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
1,120 Previous Clinical Trials
1,521,317 Total Patients Enrolled
Camino Pharma, LLCLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,033 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability to join this medical experiment?

"Per the clinicaltrials.gov website, this medical experiment is actively enlisting participants. This examination was initially posted on July 20th 2021 and recently modified on September 15th 2022."

Answered by AI

How severe are the adverse effects associated with SBP-9330?

"As this is an early phase clinical trial, the safety of SBP-9330 has been rated at a conservative 1 due to limited evidence supporting its efficacy and safety."

Answered by AI

Does the eligibility for this research include those under thirty years of age?

"The requirements for this clinical trial restrict the age range to between 18 and 55. There are 5 studies tailored for minors, while individuals 65 years of age or older have access to 131 trials."

Answered by AI

Who is eligible to take part in this medical research?

"This research is recruiting 90 individuals between the ages 18 and 55 that are seeking to quit smoking. In order for an applicant to qualify, they must fulfill a number of criteria including: being either postmenopausal or using contraception if female; having not smoked nicotine products in two years prior to study drug administration; no serious medical/mental health conditions revealed from history or exam; healthy BP, heart rate, temp., respiratory rate with no orthostatic hypotension or tachycardia at screening; agreement to comply and availability for duration of trial; BMI ≥18.5 kg/m2 & ≤ 32.0 kg/m2."

Answered by AI

How many research subjects are currently being observed in this investigation?

"Affirmative, the information existing on clinicaltrials.gov implies that this medical trial is actively enlisting participants. This project was originally publicized on July 20 2021 and has been modified as recently as September 15 2022. The total amount of patients sought for enrollment amounts to 90 across a single site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Altasciences Clinical Kansas, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A First-in-Human Study of SBP-9330 in Healthy Subjects
2021. "A First-in-Human Study of SBP-9330 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948827.
~24 spots leftby Apr 2025
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