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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Medical Food: SBD111; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Hinda and Arthur Marcus Institute for Aging Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; One capsule administered twice daily with morning and evening meals for 28 days
Experimental: SBD111	Other: Medical Food: SBD111; One capsule administered twice daily with morning and evening meals for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Solarea Bio, Inc
• Collaborators: Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): February 5, 2022

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Pro00054643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No