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Placebo

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

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

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

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 more

Other study objectives

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

17%

Diarrhea

100%

80%

60%

40%

20%

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

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

Group X: Part A1 - Single-Dose (Active; 150 mg )Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBP-9330

2021

Completed Phase 1

~90

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