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New pain drug SBS-1000 takes first step in human safety trial

NCT ID NCT05721287

Knowledge-focused Sponsor: Sparian Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a single dose of a new drug called SBS-1000 in 48 healthy adults to see if it is safe and how the body handles it. Participants were randomly assigned to receive either the drug or a placebo by IV. The main goal was to check for side effects and measure drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Started

Jan 2023

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening 3. Body mass index (BMI) within 18.0 kg/m\^2 to 33.0 kg/m\^2, inclusively 4. Minimum body weight of at least 50.0 kg at Screening 5. Willingness to comply with all study procedures 6. If female, agrees to use an acceptable contraceptive method. 7. If male, agrees to use an acceptable contraceptive method. 8. Healthy as determined by no clinically significant findings at screening and clinic admission. 9. Non- or ex-smoker Exclusion Criteria: 1. Has a current medical condition that would affect sensitivity to cold or pain 2. Personal or family history of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic, or other clinically significant disease that may interfere with the study 3. Any clinically significant illness in the 28 days prior to the first study drug administration 4. Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the participant as healthy 5. Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) 6. Any clinically significant laboratory results at screening or prior to the first drug administration 7. intake of an investigational product within 28 days prior to study drug administration. 8. Positive test for alcohol and/or drugs of abuse 9. Positive for HIV or hepatitis 10. Donation of plasma 7 days prior to study drug administration and/or donation of blood within 56 days prior to study drug administration. 11. Significant ECG abnormalities

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pain Pain

Contacts and locations

Locations

  • Altasciences Clinical Kansas

    Overland Park, Kansas, 66212, United States

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