Last updated: January 31, 2023
Sponsor: Sparian Biosciences, Inc
Overall Status: Active - Recruiting
Phase
1
Condition
Acute Pain
Pain
Treatment
N/AClinical Study ID
NCT05721287
SBS1000-AP-101
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 clinicadmission.
- Non- or ex-smoker
Exclusion
Exclusion Criteria:
- 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 clinicallysignificant disease that may interfere with the study
- Any clinically significant illness in the 28 days prior to the first study drugadministration
- 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
- 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 drugadministration
- intake of an investigational product within 28 days prior to study drugadministration.
- 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 bloodwithin 56 days prior to study drug administration.
- Significant ECG abnormalities
Study Design
Total Participants: 56
Study Start date:
January 30, 2023
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Altasciences Clinical Kansas
Overland Park, Kansas 66212
United StatesActive - Recruiting
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