Last updated: April 19, 2022
Sponsor: Synthetic Biologics Inc.
Overall Status: Completed
Phase
1
Condition
Colic
Inflammatory Bowel Disease
Infectious Colitis
Treatment
N/AClinical Study ID
NCT05045833
SB-1-020-002
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is able to read, write, and comprehend English at a sufficient level tounderstand study-related materials, has provided written informed consent before anystudy-related procedure was performed, and is willing and able to comply with alltesting and study requirements.
- Subject is a healthy male or female, at least 18 years of age.
- Subject does not use any tobacco or nicotine product (for example, cigarette, pipe, ecigarette, vape, smokeless tobacco) and has not used any tobacco or nicotine productfor at least 2 months before CRU admission.
- Subject has a BMI of 18.5 to <35 kg/m2. Note: Approximately 50% of subjects shouldhave BMI > 25 kg/m2; however, randomization is not based on BMI.
- Subject is healthy based on physical examination, clinical laboratory tests, 12-leadECG, and vital signs.
- Subject is willing to minimize the risk of inducing pregnancy from the time of signingthe ICF to at least either 90 days (males) or 30 days (females) after the last studydrug dose by following the procedures below. If male: Must agree to abstain from donating sperm for at least 90 days after thestudy drug dose. If male has a female sexual partner of childbearing potential: He must ALSO agree touse at least one of the following medically acceptable methods of contraception for atleast 90 days after the study drug dose:
- Bilateral vasectomy performed at least 1 year before screening
- Use of a condom or diaphragm plus either contraceptive sponge, foam, or jelly
- Complete abstinence from heterosexual intercourse; periodic abstinence is notacceptable If a sexually active female of childbearing potential (defined as a female afterpuberty who is not postmenopausal for at least 1 year or surgically sterile): Mustagree to use at least one of the following medically acceptable methods ofcontraception for at least 30 days after the study drug dose:
- Intrauterine device (hormonal or non-hormonal, inserted 2 or more cycles beforeScreening)
- Hormonal contraception (stable use for 2 or more cycles before Screening)administered orally or by depot injection or implant, transdermal system, orvaginal ring
- Bilateral tubal ligation
- Male partner with a bilateral vasectomy performed at least 1 year beforescreening
- Barrier contraception: Use of a condom or diaphragm plus either contraceptivesponge, foam, or jelly
- Complete abstinence from heterosexual intercourse; periodic abstinence is notacceptable
- If female, subject has a negative serum pregnancy test at Screening and upon CRUadmission.
- Subject usually has at least 1 bowel movement a day based on self-reporting.
Exclusion
Exclusion Criteria:
- Subject has a history or the presence of clinically significant cardiovascular,pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic,dermatologic, neurologic, oncologic, vascular, metabolic, collagen, or psychiatricdisease or any other condition that, in the opinion of the Investigator, wouldjeopardize the safety of the subject or the validity of the study results.
- Subject has any known malabsorption syndrome or history of gastrointestinal surgerythat could compromise the study objectives.
- Subject has used any medication (prescription or non-prescription) or herbalsupplement other than prescription hormone replacement therapy (eg, thyroid,testosterone, estrogen) within 21 days before CRU admission or, if female, has usedhormonal contraception if use has not been stable for 2 or more cycles beforeScreening.
- Subject is pregnant, breastfeeding, or not using a medically accepted method ofcontraception.
- Subject is unable to abstain from artificial sweeteners (eg, aspartame, acesulfamepotassium, advantame, saccharin, stevia, and sucralose) from CRU admission to CRUdischarge.
- Subject has a positive urine drug or alcohol test at Screening or CRU admission OR hasa history of drug/alcohol abuse within 12 months before Screening.
- Subject has donated more than 500 mL blood during the 3-month period before CRUadmission.
- Subject has known intolerance of study drug or ingredients.
- In the judgment of the Investigator, subject has any factor (eg, other treatment) thatcould invalidate the study result.
- Subject is currently enrolled in another clinical study or has received aninvestigational drug or device within 30 days or within a time period consistent witha washout period of 5 half-lives before signing the ICF, whichever is longer.
- Subject has already participated in this or a previous SYN 020 study.
Study Design
Total Participants: 40
Study Start date:
October 18, 2021
Estimated Completion Date:
March 21, 2022
Study Description
Connect with a study center
Spaulding Clinical Research LLC
West Bend, Wisconsin 53095
United StatesSite Not Available

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