COMPLETED

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

Conditions

Pain Acute Pain Arylepoxamide Safety Tolerability SBS-1000 SBS1000 6TM AEAr Agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-01-30

Study Completion:2023-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05721287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Jeff Reich, MD

STUDY_DIRECTOR

Sparian Biosciences

Study Locations (Sites)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: Sparian Biosciences, Inc

Jeff Reich, MD, STUDY_DIRECTOR, Sparian Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-30

Study Completion Date2023-08-30

Study Record Updates

Study Start Date2023-01-30

Study Completion Date2023-08-30

Terms related to this study

Keywords Provided by Researchers

Arylepoxamide
Safety
Tolerability
SBS-1000
SBS1000
6TM
AEAr Agonist

Additional Relevant MeSH Terms

Pain
Acute Pain