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RECRUITINGPHASE1

Phase 1 Study of SBS-147 in Healthy Adults

A PHASE 1, TWO-PART, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF ORALLY ADMINISTERED SBS-147 IN HEALTHY ADULTS

NCT07335913•Sparian Biosciences, Inc

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The goal of this clinical trial is to learn about the safety of SBS-147. The main questions it aims to answer are: What medical problems do participants have when taking SBS-147? Researchers will compare SBS-147 to a placebo (a look-alike substance that contains no drug) to see if SBS-147 works to treat acute pain. Participants in the single ascending dose portion will: Take SBS-147 or a placebo one time during the study Stay confined to the clinic for a period of 5 days and undergo tests, blood draws, and questionnaires. Complete an end of study visit on Day 8 Participants in the multiple ascending dose portion will: Take SBS-147 or a placebo one time per day or twice a day for 7 days Stay confined to the clinic for a period of 10 days and undergo tests, blood draws, and questionnaires. Complete an end of study visit on Day 14

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provision of signed and dated informed consent form (ICF)
•2. Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
•3. Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively
•4. Minimum body weight of at least 50.0 kg at Screening
•5. Stated willingness to comply with all study procedures and availability for the duration of the study
•6. Females of childbearing potential
•7. Healthy, as determined by protocol requirements
•8. Non- or ex-smoker for at least 90 days prior to Screening
•9. Participant is able and willing to comply with all study protocol procedures and requirements

Exclusion Criteria

•1. Female who is lactating at Screening
•2. Female who is pregnant
•3. History of significant hypersensitivity reactions (like angioedema) to any drugs
•4. Presence or history of significant surgery that may affect drug bioavailability
•5. History of significant CV, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease
•6. Meet Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for lifetime or current substance use disorder for any psychoactive substances other than nicotine or caffeine
•7. Showing suicidal tendency as per the C-SSRS administered at screening and clinic admission
•8. Any clinically significant illness in the 28 days prior to the first study drug administration
•9. Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to Screening and until the end of the study, that in the opinion of an Investigator would put into question the status of the participant as healthy
•10. Use of opioids, hypnotics, and/or sedatives in the last 30 days prior to screening
+19 more criteria

Locations (1)

AltaSciences, Inc

Cypress, California, United States

Key Dates

Start Date

January 8, 2026

Primary Completion Date

January 31, 2027

Completion Date

February 28, 2027

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Pain AcutePain

Interventions

SBS-147

DRUG

Placebo

DRUG

Contacts

Oscar McClyde

CONTACT

913-696-1601 omcclyde@altasciences.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1 Study of SBS-147 in Healthy Adults

Inclusion Criteria

Exclusion Criteria

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