Clinical trial NCT05721287: A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of SBS-1000 Administered by Intravenous Infusion to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain
Acute Pain
Keywords: Arylepoxamide
Safety
Tolerability
SBS-1000
SBS1000
6TM
AEAr Agonist
Lead sponsor: Sparian Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.

Detailed description: This study will be a single-center (clinical research unit), double-blind, placebo-controlled, randomized, adaptive, single-ascending dose study receiving either Investigational Product (IP \[SBS-1000\]) or placebo IV infusion. Up to 56 subjects will be randomized.

A total of 6 ascending dose cohorts will be used to assess the MTD of SBS-1000. Each cohort will be comprised of up to 8 subjects randomized 6:2 (IP:placebo). A sentinel group of 2 subjects randomized 1:1 (IP:placebo) will be used for each cohort with the sentinel group being dosed at least 48 hours prior to dosing the remaining subjects of the cohort, and contingent on the results of ongoing safety evaluation.

Blood samples will be collected over 72 hours postdose and urine samples over 48 hours postdose for pharmacokinetic (PK) assessments in all cohorts. Pharmacodynamic assessments will be performed throughout the study in cohorts 1 through 6. The sampling parameters may be adjusted based on the interim safety review.

Once the maximum tolerated dose (MTD) is established, dosing with the MTD or a lower dose, as determined by an interim safety review, an additional cohort (7) will occur to investigate the cardiodynamic effects of SBS-1000 using Holter monitoring. Cohort 7 will be comprised of 8 subjects randomized 6:2 (IP:placebo). No sentinel dosing administration will occur in this cohort.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF)
2. Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening
3. Body mass index (BMI) within 18.0 kg/m\^2 to 33.0 kg/m\^2, inclusively
4. Minimum body weight of at least 50.0 kg at Screening
5. Willingness to comply with all study procedures
6. If female, agrees to use an acceptable contraceptive method.
7. If male, agrees to use an acceptable contraceptive method.
8. Healthy as determined by no clinically significant findings at screening and clinic admission.
9. Non- or ex-smoker

Exclusion Criteria:

1. Has a current medical condition that would affect sensitivity to cold or pain
2. Personal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the study
3. Any clinically significant illness in the 28 days prior to the first study drug administration
4. Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy
5. Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)
6. Any clinically significant laboratory results at screening or prior to the first drug administration
7. intake of an investigational product within 28 days prior to study drug administration.
8. Positive test for alcohol and/or drugs of abuse
9. Positive for HIV or hepatitis
10. Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration.
11. Significant ECG abnormalities

Primary outcomes:
measure: Number of subjects with adverse events (AEs)
timeFrame: From start of infusion to 4 (±2) days after the last blood draw in the study
Secondary outcomes:
measure: Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000
timeFrame: From start of infusion to 72 hours post-infusion
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas
state: Kansas
Study officials:
affiliation: Sparian Biosciences
name: Jeff Reich, MD
role: STUDY_DIRECTOR
References: