A Phase 1, Randomized, Placebo-Controlled Safety and Tolerability Study Of Intravenous SBS-1000 in Healthy Adults

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a single-center, double-blind, randomized placebo-controlled, adaptive, single ascending dose study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sparian Biosciences, Inc

Criteria

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