Actively Recruiting
Phase 1 Study of SBS-147 in Healthy Adults
Led by Sparian Biosciences, Inc · Updated on 2026-03-03
80
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
Sponsors
S
Sparian Biosciences, Inc
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is part of the HEAL Initiative supported by the NIH. The purpose of this study is to learn how safe the study drug, SBS-147, is and how people's bodies respond to and process it. Researchers will also look for any side effects that may occur when taking SBS-147. Some participants will receive SBS-147, and others will receive a placebo, which looks the same but does not contain any medicine. This helps researchers fairly compare results. The study includes two parts: Single-Dose Group, where Participants receive SBS-147 or placebo one time. Multiple-Dose Group, where Participants receive SBS-147 or placebo once or twice daily for 7 days.
CONDITIONS
Official Title
Phase 1 Study of SBS-147 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Healthy male or female aged 18 to 55 years
- Body mass index between 18.0 and 32.0 kg/m2
- Minimum body weight of 50.0 kg
- Willingness to comply with study procedures and availability for study duration
- Females of childbearing potential
- Healthy status as defined by protocol
- Non-smoker or ex-smoker for at least 90 days prior to screening
- Ability and willingness to follow all study requirements
You will not qualify if you...
- Female who is pregnant or lactating
- History of significant drug hypersensitivity reactions
- History of surgery affecting drug absorption
- Significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immune disease
- Current or past substance use disorder (excluding nicotine or caffeine)
- Suicidal tendencies as assessed at screening
- Clinically significant illness within 28 days before first drug dose
- Use of prescription drugs affecting health status within 28 days or 5 half-lives before screening
- Use of opioids, hypnotics, or sedatives in last 30 days
- Chronic use of acetaminophen or NSAIDs more than 7 of 20 days during screening
- Use of St. John's Wort within 28 days prior to screening
- Use of herbal supplements within 14 days prior to screening
- Use of investigational products within 30 days prior to screening
- Positive tests for alcohol, drugs of abuse, HIV, hepatitis B or C at screening
- Any other clinical abnormalities increasing risk or affecting participation
- Recent blood or plasma donation
- Participation in prior cohorts of this study
- Abnormal vital signs or oxygen saturation at screening
- Clinically significant ECG abnormalities or family history of specific heart conditions
- History of fainting or sudden cardiac death in family
- History of gastroesophageal reflux or hiatal hernia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AltaSciences, Inc
Cypress, California, United States, 90630
Actively Recruiting
Research Team
O
Oscar McClyde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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