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A First-in-Human Study of SBP-9330 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04948827
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Sanford Burnham Prebys Medical Discovery Institute
University of California, San Diego
Information provided by (Responsible Party):
Camino Pharma, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: SBP-9330 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Part A - Single-Dose (Active)
Each Part A cohort will be randomized to either active SBP-9330 or matching placebo in increasing doses. In each cohort a sentinel group of 2 subjects will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
Drug: SBP-9330
SBP-9330 oral capsules

Placebo Comparator: Part A - Single-Dose (Placebo)
Each Part A cohort will be randomized to either active SBP-9330 or matching placebo in increasing doses. In each cohort a sentinel group of 2 subjects will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
Drug: Placebo
Placebo oral capsules

Experimental: Part A - Single-Dose Food-Effect (Active)
In this two-period food-effect cohort, each subject will receive the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects will receive 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 will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
Drug: SBP-9330
SBP-9330 oral capsules

Placebo Comparator: Part A - Single-Dose Food-Effect (Placebo)
In this two-period food-effect cohort, each subject will receive the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects will receive 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 will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
Drug: Placebo
Placebo oral capsules

Experimental: SBP-9330 - Multiple-Dose (Active)
Each Part B cohort will be randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Drug: SBP-9330
SBP-9330 oral capsules

Placebo Comparator: Placebo - Multiple-Dose (Placebo)
Each Part B cohort will be randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Drug: Placebo
Placebo oral capsules




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 52 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


Secondary Outcome Measures :
  1. Pharmacokinetics of SBP-9330: Cmax [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Maximum observed concentration (Cmax)

  2. Pharmacokinetics of SBP-9330: Tmax [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Time to reach maximum observed concentration (Tmax)

  3. Pharmacokinetics of SBP-9330: AUC 0-24 [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 24 hours post-dose ]
    Area under the concentration time curve from time 0 (dose administration) to 24 hours

  4. Pharmacokinetics of SBP-9330: AUC 0-T [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Area under the concentration time curve from time 0 (dose administration) to the time of last quantifiable concentration

  5. Pharmacokinetics of SBP-9330: AUC 0-∞ [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Area under the concentration time curve extrapolated to infinity

  6. Pharmacokinetics of SBP-9330: T½ [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Terminal elimination half-life

  7. Pharmacokinetics of SBP-9330: CL/F [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Apparent total clearance

  8. Pharmacokinetics of SBP-9330: Vz/F [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Apparent volume of distribution

  9. Pharmacokinetics of SBP-9330: C trough [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Observed concentration at the end of the dosing interval

  10. Pharmacokinetics of SBP-9330: Cτ [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Concentration at the end of the dosing interval.

  11. Pharmacokinetics of SBP-9330: AUCτ [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Area under the concentration time curve over the dosing interval at steady state, calculated from 0 to 24 hours (dosing interval)

  12. Pharmacokinetics of SBP-9330: T½, eff [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Effective half-life

  13. Pharmacokinetics of SBP-9330: CL/Fss [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Apparent total clearance at steady state

  14. Pharmacokinetics of SBP-9330: Vz/Fss [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Apparent volume of distribution at steady state

  15. Pharmacokinetics of SBP-9330: RAC(Cmax) [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Accumulation ratio evaluated by comparing Day 14 Cmax to Day 1 Cmax

  16. Pharmacokinetics of SBP-9330: RAC(AUC) [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 48 hours post-dose ]
    Accumulation ratio evaluated by comparing Day 14 AUCτ to Day 1 AUC0-24



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of written informed consent prior to the initiation of any protocol-specific procedures
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Healthy male or female subject ≥ 18 and ≤ 55 years of age
  4. Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 32.0 kg/m2
  5. Body weight ≥ 50.0 kg at Screening
  6. 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)
  7. 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.
  8. Never- or non-smoker (a non-smoker is defined as someone who completely stopped using nicotine products for at least 2 years prior to the first study drug administration
  9. 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
  10. 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.

Exclusion Criteria:

  1. Female who is lactating
  2. Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
  3. Female who is planning to become pregnant during this study or within 90 days after the last study drug administration
  4. 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
  5. Poor venous access as determined by an Investigator at Screening
  6. 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
  7. Presence of any medical condition that, in the opinion of an Investigator, poses an unacceptable risk to the subjects
  8. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug absorption
  9. 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
  10. History of malignancy within the past five years, except for successfully treated basal cell carcinoma of the skin
  11. History of suicidal ideation or suicidal behavior as per the C-SSRS questionnaire administered at Screening
  12. 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
  13. Routine or chronic use of more than three grams of acetaminophen daily
  14. Strenuous activity, sunbathing, and contact sports within 48 hours prior to (first) admission to the CRU
  15. 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
  16. History of alcohol or drug (other than caffeine) use disorder within 12 months prior to Screening
  17. Any clinically significant illness in the 28 days prior to the first study drug administration
  18. 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
  19. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration
  20. Positive test results for HIV-1/HIV-2 antibodies, hepatitis B surface antigen or hepatitis C antibody
  21. 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
  22. 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).
  23. 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
  24. Intake of an investigational product in the 30 days or 5 half-lives (whichever is longer) prior to Screening
  25. Inclusion in a previous cohort of this clinical study
  26. Employee of the contract research organization (CRO) or the Sponsor.
  27. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening
  28. Plasma donation within 7 days prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04948827


Contacts
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Contact: Vijay Hingorani, MD, PhD 858-864-8124 clinicaltrials@caminopharma.com

Locations
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United States, Kansas
Altasciences Clinical Kansas, Inc Recruiting
Overland Park, Kansas, United States, 66212
Contact    913-696-1601    regulatory@altasciences.com   
Principal Investigator: Martin Kankam, MD, PhD, MPH, FAPCR         
Sponsors and Collaborators
Camino Pharma, LLC
National Institute on Drug Abuse (NIDA)
Sanford Burnham Prebys Medical Discovery Institute
University of California, San Diego
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Responsible Party: Camino Pharma, LLC
ClinicalTrials.gov Identifier: NCT04948827    
Other Study ID Numbers: SBP-9330-101
U01DA051077 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No