Pharmacokinetics, Safety, and Tolerability of SYN-020

NCT04815993 | Completed Phase 1 FDA Drug

• 1 other identifier: SB-1-020-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile. For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.

Conditions

Enteritis Caused by Radiation (Disorder)

Outcome Measures

Primary Outcomes (2)

• SYN-020 systemic absorption

  Analysis of SYN-020 level present in blood

  Daily Day 1 through Day 5

• SYN-020 presence in feces

  Analysis of SYN-020 level present in feces

  Daily Day -1 through Day 6

Secondary Outcomes (5)

• Percentage of Participants with Changes in Clinical Laboratory Testing

  Day -1, Day 2, Day 6

• Number of Participants With Changes in Physical exam

  Day 1 and Day 6

• Number of Participants with Changes in Vital Signs

  Daily Day -1 through Day 6

• Number of Participants with Changes in Electrocardiograms

  Day -1, Day 1, Day 2, Day 6

• Immunogenicity testing

  Day 1, Day 6

Study Arms (4)

SYN-020, 5 mg

EXPERIMENTAL

6 subjects to receive a single 5 mg dose of SYN-020

Drug: SYN-020 delayed release capsule

SYN-020, 15 mg

EXPERIMENTAL

6 subjects to receive a single 15 mg dose of SYN-020

Drug: SYN-020 delayed release capsule

SYN-020, 45 mg

EXPERIMENTAL

6 subjects to receive a single 45 mg dose of SYN-020

Drug: SYN-020 delayed release capsule

SYN-020, 150 mg

EXPERIMENTAL

6 subjects to receive a single 150 mg dose of SYN-020

Drug: SYN-020 delayed release capsule

Interventions

SYN-020 delayed release capsule DRUG

SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.

Also known as: Intestinal Alkaline Phosphatase

SYN-020, 15 mg; SYN-020, 150 mg; SYN-020, 45 mg; SYN-020, 5 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subject is a healthy male or female, aged 18 through 50 years, inclusive.
• Subject does not use any tobacco or nicotine product (eg, cigarette, pipe, e-cigarette, vape) and has not used any tobacco or nicotine product for at least 2 months before Day -1.
• Subject has a BMI of 18.5 to 27 kg/m2 for initial cohorts or, for exploratory cohorts, ≥ 27.1 kg/m2. For Cohorts 1 through 4, if insufficient subjects are available to meet this criterion, subjects with a BMI up to 29 kg/m2 may be included with written authorization from the Sponsor.
• Subject is healthy based on physical examination, clinical laboratory tests, 12-lead ECG, and vital signs.
• Subject is willing to minimize the risk of inducing pregnancy from the time of signing the informed consent form (ICF) to at least either 90 days (males) or 30 days (females) after the study drug dose.
• If female, subject has a negative serum pregnancy test at Screening and on Day -1 (CRU admission).
• Subject usually has at least 1 bowel movement a day based on self-reporting.

You may not qualify if:

• 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.
• Subject has any known malabsorption syndrome or history of gastrointestinal surgery that could compromise the study objectives.
• Subject is pregnant, breastfeeding, or not using a medically accepted method of contraception.
• Subject is unable to abstain from artificial sweeteners (eg, aspartame, acesulfame potassium, advantame, saccharin, stevia, and sucralose) from CRU admission to the end of study participation.
• 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.
• Subject has donated more than 500 mL blood during the 3-month period before Day -1.
• Subject has known intolerance of study drug/ingredients.
• In the judgment of the Investigator, subject has any factor (eg, other treatment) that could invalidate the study result.
• 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.
• Subject has already participated in this study.

Sponsors & Collaborators

• Theriva Biologics, Inc.: lead
• Spaulding Clinical Research LLC: collaborator

Study Sites (1)

Spaulding Clinical Research LLC

West Bend, Wisconsin, 53095, United States

Location

Study Officials

• Carlos Sanabria, MD

  Spaulding Clinical Research LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single ascending dose

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 25, 2021
• Study Start: March 22, 2021
• Primary Completion: May 18, 2021
• Study Completion: September 30, 2021
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)