A First-in-Human Study of SBP-9330 in Healthy Subjects
VH
Overseen ByVijay Hingorani, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Camino Pharma, LLC
Trial Summary
What is the purpose of this trial?
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.
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.
How does the drug SBP-9330 differ from other treatments for this condition?
Eligibility Criteria
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
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A person who has not smoked cigarettes for at least two years.
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Timeline
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)
Treatment Details
Interventions
- Placebo
- SBP-9330
Participant Groups
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
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 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
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 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 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
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.
Find a Clinic Near You
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+
References
Mucosal [SIgA] and serum [IgG] immunologic responses in the community after a single intra-nasal immunization with a new inactivated trivalent influenza vaccine. [2019]
Adjuvantation of Pulmonary-Administered Influenza Vaccine with GPI-0100 Primarily Stimulates Antibody Production and Memory B Cell Proliferation. [2020]
Quillaja brasiliensis saponins induce robust humoral and cellular responses in a bovine viral diarrhea virus vaccine in mice. [2018]
Evaluating functional antibodies in rhesus monkeys immunized with hepatitis B virus surface antigen vaccine with novel adjuvant formulations. [2017]
Preclinical evaluation of the saponin derivative GPI-0100 as an immunostimulating and dose-sparing adjuvant for pandemic influenza vaccines. [2011]
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