Smoking CessationPhase 1NCT04948827
A First-in-Human Study of SBP-9330 in Healthy Subjects
A Phase 1 study testing SBP-9330 in people with Smoking Cessation, run by Camino Pharma, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SBP-9330
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 6 Mar 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent prior to the initiation of any protocol-specific procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy male or female subject ≥ 18 and ≤ 55 years of age
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 32.0 kg/m2
- Body weight ≥ 50.0 kg at Screening
- A female subject must meet at least one of the following criteria: a. Is of childbearing potential and agrees to use an acceptable contraceptive method. b. Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e., at least 1 year without menses prior to the first study drug administration without an alternative medical condition and confirmed with a serum follicle-stimulating hormone [FSH] > 40 IU/L at Screening)
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- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from the first admission to the CRU until 90 days after the last study drug administration.
- Part A and B only: Never- or nonsmoker (a nonsmoker is defined as someone who completely stopped using nicotine products for at least 2 years prior to the first study drug administration)
- Have no clinically significant medical or mental health conditions captured in the medical history or evidence of clinically significant findings on the physical examination and/or ECG, as determined by an Investigator
- No clinically significant abnormalities in blood pressure, heart rate, body temperature and respiratory rate and no evidence of orthostatic hypotension or postural tachycardia at Screening.
- Part C Only:
- Are current tobacco cigarette smokers who smoke an average of 10 or more cigarettes per day in the 30 days prior to Screening
- Expired breath CO level ≥10 parts per million (ppm) at Screening and prior to the first study drug administration
- Positive test result for cotinine at Screening and prior to the first study drug administration
- Are not motivated to try to quit smoking from Screening through 30 days from the first study drug administration
Who cannot join
- Female who is lactating
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female who is planning to become pregnant during this study or within 90 days after the last study drug administration
- Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after the last study drug administration
- Poor venous access as determined by an Investigator at Screening
- History of significant hypersensitivity to SBP-9330 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
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- Presence of any medical condition that, in the opinion of an Investigator, poses an unacceptable risk to the subjects
- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug absorption
- Evidence or history of clinically significant cardiovascular, pulmonary, hematologic, psychiatric (including mood and substance use disorders), neurological (including migraines, seizures, and epilepsy), endocrine, renal, hepatic, gastrointestinal, immunologic or dermatologic disease
- History of malignancy within the past five years, except for successfully treated basal cell carcinoma of the skin
- History of suicidal ideation or suicidal behavior as per the C-SSRS questionnaire administered at Screening
- Evidence or history of significant psychiatric disease or any DSM-5 disorder as assessed by the Mini International Neuropsychiatric Interview (M.I.N.I.) administered at Screening
- Routine or chronic use of more than three grams of acetaminophen daily
- Strenuous activity, sunbathing, and contact sports within 48 hours prior to (first) admission to the CRU
- Current alcohol consumption exceeding two standard drinks per day on average (1 standard drink=10 grams of alcohol) for male subjects and one standard drink per day on average for female subjects
- History of alcohol or drug (other than caffeine) use disorder within 12 months prior to Screening
- Any clinically significant illness in the 28 days prior to the first study drug administration
- QTcF interval (QT interval corrected for heart rate according to Fridericia) > 450 ms for males and > 470 ms for females at Screening or on Day -1
- Parts A and B only: Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration
- Positive test results for HIV-1/HIV-2 antibodies, hepatitis B surface antigen or hepatitis C antibody
- Consumption of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) or over-the-counter medications and nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) or St. John's Wort within 14 days prior to the first study drug administration
- Consumption of other prescription and over-the-counter medication not specifically excluded by Exclusion Criterion 21 including health supplements and herbal remedies within 7 days prior to the first study drug administration (an exception is made for paracetamol [acetaminophen], which is allowed up to admission to the clinic).
- Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
- Intake of an investigational product in the 30 days or 5 half-lives (whichever is longer) prior to Screening
- Inclusion in a previous cohort of this clinical study
- Employee of the contract research organization (CRO) or the Sponsor.
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
- Plasma donation within 7 days prior to Screening
- Part C Only:
- History of generalized rash reaction to any drugs
- Positive test result (except cotinine) for alcohol and/or drugs of abuse at Screening or prior to the first study drug administration
- Use of smoking cessation aids (NRT, bupropion, or varenicline) within 30 days prior to the first study drug administration
- Unable to abstain from smoking tobacco cigarettes for at least 1 hour before and 2 hours after study drug administration
- Unable to abstain from using nicotine-containing products other than tobacco cigarettes (e.g., pipes, cigars, e-cigarettes or vapes, nicotine topical patches, nicotine gum, or nicotine lozenges) during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SBP-9330 (With a Nested Food-Effect Arm) After Oral Administration in Healthy Subjects
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
- Being tested
- SBP-9330, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBP-9330Drug
SBP-9330 oral capsules
PlaceboDrug
Placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Part A1 - Single-Dose (Active; 150 mg ) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part A3 - Single-Dose Food Effect (Active; 225 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part A2 - Single-Dose (Active; 300 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part A4 - Single-Dose (Active; 450 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part A5 - Single-Dose (Active; 600 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part A - Single-Dose (Placebo; pooled) | Placebo comparator | 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. Receives: Drug: Placebo |
| Part B1 - Multiple-Dose Active (150 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part B2 - Multiple-Dose Active (225 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part B3 - Multiple-Dose Active (300 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part B - Multiple-Dose Placebo (pooled) | Placebo comparator | 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. Receives: Drug: Placebo |
| Part C1 - Smoker Phase (Active; 150 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part C2 - Smoker Phase (Active; 225 mg) | Experimental | 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. Receives: Drug: SBP-9330 |
| Part C - Smoker Phase (Placebo; pooled) | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results
Measured: Part A: 8 days Part B: 21 days Part C: 21 days
Secondary outcomes (16)
Pharmacokinetics of SBP-9330: Cmax
Maximum observed concentration (Cmax)
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Tmax
Time to reach maximum observed concentration (Tmax)
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-24
Area under the concentration time curve from time 0 (dose administration) to 24 hours
Measured: PK samples were obtained at selected timepoints from pre-dose until 24 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-T
Area under the concentration time curve from time 0 (dose administration) to the time of last quantifiable concentration
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-∞
Area under the concentration time curve extrapolated to infinity
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: T½
Terminal elimination half-life
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: CL/F
Apparent total clearance
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Vz/F
Apparent volume of distribution
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: C Trough
Observed concentration at the end of the dosing interval
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Cτ
Concentration at the end of the dosing interval.
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUCτ
Area under the concentration time curve over the dosing interval at steady state, calculated from 0 to 24 hours (dosing interval)
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: T½, Eff
Effective half-life
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: CL/Fss
Apparent total clearance at steady state
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Vz/Fss
Apparent volume of distribution at steady state
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: RAC(Cmax)
Accumulation ratio evaluated by comparing Day 14 Cmax to Day 1 Cmax
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: RAC(AUC)
Accumulation ratio evaluated by comparing Day 14 AUCτ to Day 1 AUC0-24
Measured: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start20 Jul 2021
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camino Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Sanford Burnham Prebys, University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948827
- Sponsor's protocol ID
- SBP-9330-101
- Other IDs
- U01DA051077
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2021
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SBP-9330 (With a Nested Food-Effect Arm) After Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04948827
- Acronym / sponsor ID
- SBP-9330-101
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Camino Pharma, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), Sanford Burnham Prebys, University of California, San Diego
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part A1 - Single-Dose (Active; 150 mg ) | Experimental | Drug: SBP-9330In 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. |
| Part A3 - Single-Dose Food Effect (Active; 225 mg) | Experimental | Drug: SBP-9330In 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. |
| Part A2 - Single-Dose (Active; 300 mg) | Experimental | Drug: SBP-9330In 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. |
| Part A4 - Single-Dose (Active; 450 mg) | Experimental | Drug: SBP-9330In 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. |
| Part A5 - Single-Dose (Active; 600 mg) | Experimental | Drug: SBP-9330In 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. |
| Part A - Single-Dose (Placebo; pooled) | Placebo comparator | Drug: PlaceboIn 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. |
| Part B1 - Multiple-Dose Active (150 mg) | Experimental | Drug: SBP-9330In 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. |
| Part B2 - Multiple-Dose Active (225 mg) | Experimental | Drug: SBP-9330In 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. |
| Part B3 - Multiple-Dose Active (300 mg) | Experimental | Drug: SBP-9330In 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. |
| Part B - Multiple-Dose Placebo (pooled) | Placebo comparator | Drug: PlaceboIn 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. |
| Part C1 - Smoker Phase (Active; 150 mg) | Experimental | Drug: SBP-9330In 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. |
| Part C2 - Smoker Phase (Active; 225 mg) | Experimental | Drug: SBP-9330In 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. |
| Part C - Smoker Phase (Placebo; pooled) | Placebo comparator | Drug: PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Provision of written informed consent prior to the initiation of any protocol-specific procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy male or female subject ≥ 18 and ≤ 55 years of age
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 32.0 kg/m2
- Body weight ≥ 50.0 kg at Screening
Key exclusion criteria (34 listed)
- Female who is lactating
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female who is planning to become pregnant during this study or within 90 days after the last study drug administration
- Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after the last study drug administration
- Poor venous access as determined by an Investigator at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBP-9330SBP-9330 oral capsules | Drug | Part A1 - Single-Dose (Active; 150 mg ), Part A2 - Single-Dose (Active; 300 mg), Part A3 - Single-Dose Food Effect (Active; 225 mg), Part A4 - Single-Dose (Active; 450 mg), Part A5 - Single-Dose (Active; 600 mg), Part B1 - Multiple-Dose Active (150 mg), Part B2 - Multiple-Dose Active (225 mg), Part B3 - Multiple-Dose Active (300 mg), Part C1 - Smoker Phase (Active; 150 mg), Part C2 - Smoker Phase (Active; 225 mg) |
| PlaceboPlacebo oral capsules | Drug | Part A - Single-Dose (Placebo; pooled), Part B - Multiple-Dose Placebo (pooled), Part C - Smoker Phase (Placebo; pooled) |
Primary outcome
Number of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Part A: 8 days Part B: 21 days Part C: 21 days
Number of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results
16 secondary outcomes
Pharmacokinetics of SBP-9330: Cmax
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Tmax
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-24
Time frame: PK samples were obtained at selected timepoints from pre-dose until 24 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-T
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUC 0-∞
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: T½
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: CL/F
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Vz/F
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: C Trough
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Cτ
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: AUCτ
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: T½, Eff
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: CL/Fss
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: Vz/Fss
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: RAC(Cmax)
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Pharmacokinetics of SBP-9330: RAC(AUC)
Time frame: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBP-9330 in people with Smoking Cessation, run by Camino Pharma, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Part A: 8 days Part B: 21 days Part C: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.