Phase 1 Study of SBS-147 in Healthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSparian Biosciences, Inc
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form (ICF)
Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively
Minimum body weight of at least 50.0 kg at Screening
Disqualifiers
Female who is lactating at Screening
Female who is pregnant
History of significant hypersensitivity reactions (like angioedema) to any drugs
Presence or history of significant surgery that may affect drug bioavailability
Trial design
Treatments tested in this trial
- SBS-147
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sparian Biosciences, Inc
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Altasciences Company Inc.
Collaborator
Source ClinicalTrials.gov