A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05721287|
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : February 10, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Pain Acute Pain||Drug: SBS-1000 Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 30, 2023|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||June 2024|
Active Comparator: SBS-1000
SBS-1000 administered as a single continuous IV infusion over 60 minutes
Other Name: arylepoxamide agonist
Placebo Comparator: Placebo
Normal saline (0.9% sodium chloride [NaCl])
Normal saline (0.9% sodium chloride [NaCl]) administered as a single dose IV infusion over 60 minutes
Other Name: sodium chloride
- Number of subjects with adverse events (AEs) [ Time Frame: From start of infusion to 4 (±2) days after the last blood draw in the study ]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
- Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000 [ Time Frame: From start of infusion to 72 hours post-infusion ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 59 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Provision of signed and dated informed consent form (ICF)
- Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening
- Body mass index (BMI) within 18.0 kg/m^2 to 33.0 kg/m^2, inclusively
- Minimum body weight of at least 50.0 kg at Screening
- Willingness to comply with all study procedures
- If female, agrees to use an acceptable contraceptive method.
- If male, agrees to use an acceptable contraceptive method.
- Healthy as determined by no clinically significant findings at screening and clinic admission.
- Non- or ex-smoker
- Has a current medical condition that would affect sensitivity to cold or pain
- 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
- Any clinically significant illness in the 28 days prior to the first study drug administration
- 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
- Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Any clinically significant laboratory results at screening or prior to the first drug administration
- intake of an investigational product within 28 days prior to study drug administration.
- Positive test for alcohol and/or drugs of abuse
- Positive for HIV or hepatitis
- Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration.
- Significant ECG abnormalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05721287
|Contact: Lissette Altoro, MDfirstname.lastname@example.org|
|United States, Kansas|
|Altasciences Clinical Kansas||Recruiting|
|Overland Park, Kansas, United States, 66212|
|Contact: Martin Kankam, MD 913-696-1601 Regulatory@altasciences.com|
|Principal Investigator: Martin Kankam, MD|
|Study Director:||Jeff Reich, MD||Sparian Biosciences|
|Responsible Party:||Sparian Biosciences, Inc|
|Other Study ID Numbers:||
|First Posted:||February 10, 2023 Key Record Dates|
|Last Update Posted:||February 10, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|