SBP-9330 for Smoking Cessation

Overseen By Vijay Hingorani, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Camino Pharma, LLC

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Pregnancy, Cardiovascular, Psychiatric, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SBP-9330 to observe its behavior in healthy individuals, both smokers and nonsmokers. The main goal is to understand how the body processes different doses and the effects of food on the treatment's absorption. Participants will receive either the treatment or a placebo (a substance with no active drug) for comparison. This trial suits healthy individuals who are nonsmokers or current smokers who smoke at least 10 cigarettes a day and are not trying to quit. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants to stop taking any prescription or over-the-counter medications, including health supplements and herbal remedies, at least 7 days before the study starts, except for hormonal contraceptives, hormone replacement therapy, and acetaminophen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that healthy nonsmokers have tolerated SBP-9330 well, with no serious side effects reported. Tests have used doses much higher than those planned for the current trials, suggesting that the starting doses are likely safe. So far, the data appears promising for safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SBP-9330 because it introduces a novel approach to managing conditions that may involve inflammation or other pathways typically targeted by traditional treatments. Unlike many current treatments which rely on well-known mechanisms, SBP-9330 works by targeting a new pathway, potentially offering benefits like improved efficacy or fewer side effects. Additionally, the study is exploring various dosages and conditions, such as effects in smokers versus nonsmokers, which could lead to more personalized treatment options in the future. This innovative approach has the potential to fill gaps left by existing therapies and improve patient outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that SBP-9330 might help treat nicotine addiction. In studies with rats, the drug quickly and effectively reduced nicotine addiction and helped prevent relapse. Early tests in humans, including this trial, have demonstrated that SBP-9330 is safe and well tolerated, with no serious side effects. Participants in this trial will receive SBP-9330 in various dosages or a placebo. Studies also found that SBP-9330 reduced the amount of nicotine animals consumed, suggesting it could help people cut down or quit smoking. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Male subjects who are not surgically sterilized must agree to use contraception and not donate sperm from the time they are admitted to the CRU until 90 days after the last study drug administration.

A female subject must meet at least one of the following criteria: Is of childbearing potential and agrees to use an acceptable contraceptive method

) A person who has not smoked cigarettes for at least two years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Single-Ascending Dose (SAD)

Participants receive single ascending doses of SBP-9330 or placebo, with a food-effect cohort included

8 days

Multiple visits (in-person)

Multiple-Ascending Dose (MAD)

Participants receive multiple ascending doses of SBP-9330 or placebo for 14 consecutive days

21 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SBP-9330

How Is the Trial Designed?

Group I: Part C2 - Smoker Phase (Active; 225 mg) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Group 1 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 Group 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Camino Pharma, LLC

Lead Sponsor

Trials

1

Recruited

90+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Sanford Burnham Prebys

Collaborator

Trials

1

Recruited

90+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Sanford Burnham Prebys Medical Discovery Institute

Collaborator

Trials

1

Recruited

90+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10829189

Project Details - NIH RePORTER To date, the data for the healthy nonsmokers have been unblinded and analyzed, revealing that SBP-9330 was well tolerated, with no serious adverse events or ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04948827/Prot_000.pdf

a randomized, double-blind, placebo-controlled, first-in- ... The primary in vivo pharmacology data showed that SBP-9330 had acute and chronic efficacy in rat models of both nicotine dependence and relapse without ...

3. reporter.nih.gov reporter.nih.gov/project-details/8599061

Medication development of a novel therapeutic for smoking ... Results of this application could lead to a new medication to treat nicotine dependence, reducing enormous costs to public health and providing perhaps the ...

4. sbpdiscovery.org sbpdiscovery.org/press/from-tobacco-to-alcohol-to-opioids-sanford-burnham-prebys-researchers-are-pursuing-novel-leads/

From tobacco to alcohol to opioids ... In preclinical studies, SBP-9330 reduced nicotine self-administration in animal studies. In a Phase 1 clinical trial, the compound was found to ...

5. prnewswire.com prnewswire.com/news-releases/camino-pharma-initiates-phase-1-study-of-sbp-9330-in-development-for-the-treatment-of-tobacco-use-disorder-301362251.html

Camino Pharma initiates Phase 1 study of SBP-9330 in ... The goal of the study is to determine the safety, tolerability and pharmacokinetic profile of SBP-9330 in humans and to determine a safe dose ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04948827

A First-in-Human Study of SBP-9330 in Healthy Subjects A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending ...

7. sbpdiscovery.org sbpdiscovery.org/sanford-burnham-prebys-drug-enters-phase-1-study-for-treatment-of-tobacco-use/

Sanford Burnham Prebys drug enters Phase 1 study for the ... The goal of the study is to determine the safety, tolerability and pharmacokinetic profile of SBP-9330 in humans and to determine a safe dose ...

8. withpower.com withpower.com/trial/phase-1-6-2021-e4d21

A First-in-Human Study of SBP-9330 in Healthy Subjects SBP-9330, also known as a placebo or dummy treatment, is unique because it is used as a control in clinical trials to compare the effects of active treatments.