Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple-ascending-dose study to assess the PK, safety, and tolerability of SYN-020 oral delayed release capsules (SYN 020) in healthy adults. At least 1 exploratory PD endpoint will also be assessed.

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

Details

• Lead Sponsor: Synthetic Biologics Inc.
• Collaborator: Spaulding Clinical Research LLC

Criteria

Inclusion Criteria:

1. Subject is able to read, write, and comprehend English at a sufficient level to understand study-related materials, has provided written informed consent before any study-related procedure was performed, and is willing and able to comply with all testing and study requirements.

2. Subject is a healthy male or female, at least 18 years of age.

3. Subject does not use any tobacco or nicotine product (for example, cigarette, pipe, e cigarette, vape, smokeless tobacco) and has not used any tobacco or nicotine product for at least 2 months before CRU admission.

4. Subject has a BMI of 18.5 to <35 kg/m2. Note: Approximately 50% of subjects should have BMI > 25 kg/m2; however, randomization is not based on BMI.

5. Subject is healthy based on physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.

6. Subject is willing to minimize the risk of inducing pregnancy from the time of signing the ICF to at least either 90 days (males) or 30 days (females) after the last study drug dose by following the procedures below.

If male: Must agree to abstain from donating sperm for at least 90 days after the study drug dose.

If male has a female sexual partner of childbearing potential: He must ALSO agree to use at least one of the following medically acceptable methods of contraception for at least 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 not acceptable

If a sexually active female of childbearing potential (defined as a female after puberty who is not postmenopausal for at least 1 year or surgically sterile): Must agree to use at least one of the following medically acceptable methods of contraception for at least 30 days after the study drug dose:

• Intrauterine device (hormonal or non-hormonal, inserted 2 or more cycles before Screening)

• Hormonal contraception (stable use for 2 or more cycles before Screening) administered orally or by depot injection or implant, transdermal system, or vaginal ring

• Bilateral tubal ligation

• Male partner with a bilateral vasectomy performed at least 1 year before screening

• Barrier contraception: Use of a condom or diaphragm plus either contraceptive sponge, foam, or jelly

• Complete abstinence from heterosexual intercourse; periodic abstinence is not acceptable

7. If female, subject has a negative serum pregnancy test at Screening and upon CRU admission.

8. Subject usually has at least 1 bowel movement a day based on self-reporting.

Exclusion Criteria:

1. 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 psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.

2. Subject has any known malabsorption syndrome or history of gastrointestinal surgery that could compromise the study objectives.

3. Subject has used any medication (prescription or non-prescription) or herbal supplement other than prescription hormone replacement therapy (eg, thyroid, testosterone, estrogen) within 21 days before CRU admission or, if female, has used hormonal contraception if use has not been stable for 2 or more cycles before Screening.

4. Subject is pregnant, breastfeeding, or not using a medically accepted method of contraception.

5. Subject is unable to abstain from artificial sweeteners (eg, aspartame, acesulfame potassium, advantame, saccharin, stevia, and sucralose) from CRU admission to CRU discharge.

6. Subject has a positive urine drug or alcohol test at Screening or CRU admission OR has a history of drug/alcohol abuse within 12 months before Screening.

7. Subject has donated more than 500 mL blood during the 3-month period before CRU admission.

8. Subject has known intolerance of study drug or ingredients.

9. In the judgment of the Investigator, subject has any factor (eg, other treatment) that could invalidate the study result.

10. Subject is currently enrolled in another clinical study or has received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the ICF, whichever is longer.

11. Subject has already participated in this or a previous SYN 020 study.