SBS-147 Safety Study

OM
Overseen ByOscar McClyde
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

JR

Jeff Reich, MD

Principal Investigator

Sparian Biosciences

Are You a Good Fit for This Trial?

Healthy adults aged 18-55, with a BMI of 18.0 to 32.0 kg/m2 and weighing at least 50 kg can join this trial. Participants must be willing to follow the study's procedures for its duration, non-smokers or have quit smoking for at least 90 days, and females must be able to bear children.

Inclusion Criteria

I am a woman who can become pregnant.
I have signed the informed consent form.
I am a healthy adult between 18 and 55 years old.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-Dose Group

Participants receive a single dose of SBS-147 or placebo and stay confined to the clinic for 5 days

8 days
1 visit (in-person)

Multiple-Dose Group

Participants receive SBS-147 or placebo once or twice daily for 7 days and stay confined to the clinic for 10 days

14 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SBS-147

Trial Overview

The trial is testing SBS-147's safety and how it affects the body compared to a placebo (no medicine). It has two parts: one where participants take a single dose of SBS-147 or placebo, and another where they take it once or twice daily for seven days.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Single Ascending DoseExperimental Treatment2 Interventions
Group II: Multiple Ascending DoseExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sparian Biosciences, Inc

Lead Sponsor

Trials
1
Recruited
60+

Altasciences Company Inc.

Industry Sponsor

Trials
18
Recruited
860+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+