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Recruiting
NCT05721287
A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults
Conditions: Pain, Acute Pain
Sex: All
Ages: 18 Years – 59 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 56
Sponsor: Sparian Biosciences, Inc
Location: United States
Summary
This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.
Eligibility Criteria
Inclusion Criteria:Provision of signed and dated informed consent form (ICF)Healthy adult male or female, aged 18 to 59 years, inclusive, at ScreeningBody mass index (BMI) within 18.0 kg/m^2 to 33.0 kg/m^2, inclusivelyMinimum body weight of at least 50.0 kg at ScreeningWillingness to comply with all study proceduresIf 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-smokerExclusion Criteria:Has a current medical condition that would affect sensitivity to cold or painPersonal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the studyAny clinically significant illness in the 28 days prior to the first study drug administrationUse 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 healthyRoutine 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 administrationintake of an investigational product within 28 days prior to study drug administration.Positive test for alcohol and/or drugs of abusePositive for HIV or hepatitisDonation 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
Source: ClinicalTrials.gov (NCT05721287). StuddyBuddy aggregates publicly available trial information.