Phase 1 Study of SBS-147 in Healthy Adults

NCT07335913 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SBS147-AP-107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Acute; Pain

Keywords

Arylepoxamide; AEAr Agonist; 6TM; Tolerability; Safety; SBS-147; SBS147

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  To assess the number of treatment emergent adverse events experienced in participants after a single dose of SBS-147

  8 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at ascending doses

  Assess the number of treatment emergent adverse events experienced by participants of SBS-147 after multiple dose oral administration in healthy adults.

  14 days

Secondary Outcomes (2)

• Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)

  0-12 hours, 0-24 hours, and extrapolated to infinity after dosing

• Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses

  Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Single dose of SBS-147 or a placebo given during trial

Drug: SBS-147; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

SBS-147 or placebo given repeatedly over several days during the trial

Drug: SBS-147; Drug: Placebo

Interventions

SBS-147 DRUG

Experimental therapeutic

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

Placebo comparator

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Females of childbearing potential
• Healthy, as determined by protocol requirements
• Non- or ex-smoker for at least 90 days prior to Screening
• Participant is able and willing to comply with all study protocol procedures and requirements

You may not qualify if:

• 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
• History of significant CV, pulmonary, hematologic, neurologic, psychiatric, endocrine, infectious, or immunologic disease
• 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
• Showing suicidal tendency as per the C-SSRS administered at screening and clinic admission
• Any clinically significant illness in the 28 days prior to the first study drug administration
• 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
• Use of opioids, hypnotics, and/or sedatives in the last 30 days prior to screening
• Routine or chronic use of acetaminophen or nonsteroidal anti-inflammatory drugs for more than 7 of the 20 days during the screening period.
• Use of St. John's Wort in the 28 days prior to Screening
• Use of any herbal supplements (including Kratom) the 14 days prior to Screening
• Intake of an Investigational Product (IP) in the 30 days prior to Screening
• Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration

Sponsors & Collaborators

• Sparian Biosciences, Inc: lead
• Altasciences Company Inc.: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

AltaSciences, Inc

Cypress, California, 90630, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff Reich, MD

  Sparian Biosciences

  STUDY DIRECTOR

Central Study Contacts

Oscar McClyde

CONTACT

913-696-1601; omcclyde@altasciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)