Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults

Healthy Clinical Trial

Official title:

Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206864
• Other study ID #: Pro00054643
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 5, 2022

Study information

• Verified date: April 2022
• Source: Solarea Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol

3. Age 18-70

4. Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or placebo

5. Willing to comply with protocol and report on compliance and side effects during study period

6. Body Mass Index between 18.5 and 35 kg/m2

7. Normal cardiovascular parameters, systolic blood pressure = 155 mm Hg, diastolic blood pressure = 95 mm Hg)

Exclusion Criteria:

1. Are currently taking probiotic or prebiotic supplements, or have taken them in the past 30 days

2. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study

3. Known or suspected allergies to probiotics

4. Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on day of enrollment.

5. Major surgery or endoscopy within last 3 months.

6. Subject is a smoker

7. Subject has a history of drug and/or alcohol abuse at the time of enrolment

8. Presence of any of the following:

9. Abnormal vital signs or clinically significant systems abnormalities based on screening questionnaire

10. Indwelling catheter or implanted hardware/prosthetic device or feeding tube

11. Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug)

12. Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease

13. History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease

14. Underlying structural heart disease or previous history of endocarditis or valve replacement

15. Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm3

16. History of cancer excluding non-melanoma skin cancers or cancer more than 10 years ago

17. History of collagen vascular disease

18. Active TB

19. Women only - pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test during screening or within 24 hours of first dose of study drug.

20. Screening laboratory tests greater than upper normal limit (ULN) or less than lower

normal limit (LLN):

1. WBCs < LLN or > ULN

2. Neutrophils < 1500/µl (1.5 x109/L)

3. Platelets < 100 x 10³/µl (100 x 109/L)

4. Haemoglobin < 9.0 g/dl (90 g/L) f. GFR of > 40 mL/minute g. AST > 3 x upper limit of normal h. ALT > 3 x upper limit of normal i. Total Bilirubin > 1.5 x upper limit of normal

21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Medical Food: SBD111
One capsule administered twice daily with morning and evening meals for 28 days
• Placebo
One capsule administered twice daily with morning and evening meals for 28 days

Locations

Country	Name	City	State
United States	Hinda and Arthur Marcus Institute for Aging Research	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Solarea Bio, Inc	Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composition and function of the gut microbiome and presence of SBD111 in stool specimens by shotgun metagenomic sequencing		Day-0 to Day-28 and Day-56 (washout)
Primary	Safety as assessed by incidence of adverse advents	Occurrence of adverse events defined as a Grade II-IV toxicity (FDA's Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials, September 2007), that are possibly or probably related to administration of SBD111	day-0 to day-28
Secondary	Gastrointestinal Tolerability as assessed by Gastrointestinal Tolerability Questionnaire	Occurrence of gastrointestinal intolerability symptoms defined as a Grade II-IV toxicity	day-0 to day-28