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

NCT04948827 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: SBP-9330-101U01DA051077
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

  Part A: 8 days Part B: 21 days Part C: 21 days

Secondary Outcomes (16)

• Pharmacokinetics of SBP-9330: Cmax

  PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose

• Pharmacokinetics of SBP-9330: Tmax

  PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose

• Pharmacokinetics of SBP-9330: AUC 0-24

  PK samples were obtained at selected timepoints from pre-dose until 24 hours post-dose

• Pharmacokinetics of SBP-9330: AUC 0-T

  PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose

• Pharmacokinetics of SBP-9330: AUC 0-∞

  PK samples were obtained at selected timepoints from pre-dose until 48 hours post-dose

Other Outcomes (5)

• Expired Carbon Monoxide (ECO) Level

  Daily from Screening through Day 14

• Plasma Cotinine Level

  Predose, Day 7 and Day 14

• Number of Cigarettes Smoked

  Daily from Screening through Day 14

Study Arms (13)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

SBP-9330 DRUG

SBP-9330 oral capsules

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)

Placebo DRUG

Placebo oral capsules

Part A - Single-Dose (Placebo; pooled); Part B - Multiple-Dose Placebo (pooled); Part C - Smoker Phase (Placebo; pooled)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Camino Pharma, LLC: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Sanford Burnham Prebys: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Altasciences Clinical Kansas, Inc

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Gonul Velicelebi
• Organization: Camino Pharma

gonul@caminopharma.com

858-201-2901

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 2, 2021
• Study Start: July 20, 2021
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)