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

Last updated: January 31, 2023
Sponsor: Sparian Biosciences, Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT05721287
SBS1000-AP-101
  • Ages 18-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 clinicadmission.
  9. Non- or ex-smoker

Exclusion

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 clinicallysignificant disease that may interfere with the study
  3. Any clinically significant illness in the 28 days prior to the first study drugadministration
  4. Use of any prescription drugs in the 28 days prior to the first study drugadministration, that in the opinion of an investigator would put into question thestatus 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 drugadministration
  7. intake of an investigational product within 28 days prior to study drugadministration.
  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 bloodwithin 56 days prior to study drug administration.
  11. Significant ECG abnormalities

Study Design

Total Participants: 56
Study Start date:
January 30, 2023
Estimated Completion Date:
June 30, 2024

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.

Connect with a study center

  • Altasciences Clinical Kansas

    Overland Park, Kansas 66212
    United States

    Active - Recruiting

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