A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721287
• Other study ID #: SBS1000-AP-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: Sparian Biosciences, Inc
• Contact: Lissette Altoro, MD
• Phone: 913-696-1601
• Email: laltoro[@]altasciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• SBS-1000
SBS-1000 administered as a single continuous IV infusion over 60 minutes
• Placebo
Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes

Locations

Country	Name	City	State
United States	Altasciences Clinical Kansas	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sparian Biosciences, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events (AEs)	Adverse events as assessed by electrocardiogram, vital signs, end-tidal carbon dioxide, oxygen saturation, physical examination, clinical laboratory tests, OAAS, C-SSRS, slit-lamp examination, gastrointestinal/esophageal assessment and concomitant medications	From start of infusion to 4 (±2) days after the last blood draw in the study
Secondary	Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000	Assessment of systemic pharmacokinetics (PK) and urinary excretion of SBS-1000 by evaluation of AUC, Cmax, tmax, Ke t 1/2, Cl, V and Urine PK	From start of infusion to 72 hours post-infusion