NCT04815993

Pharmacokinetics, Safety, and Tolerability of SYN-020

A Single Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN-020 Delayed Release Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Theriva Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Intestinal alkaline phosphatase (IAP) is a naturally occurring enzyme produced by the small intestine in all mammals, including humans, and is considered essential for promoting normal gastrointestinal (GI) function and maintaining proper gut homeostasis, as well as appearing to play a pivotal role in the mediation of inflammation. SYN-020 is a recombinant bovine IAP isotype II being developed by Synthetic Biologics, Inc. to reduce the cumulative GI toxicity and inflammation that can be associated with repeat administration of radiation in patients with cancer. 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, with 6 subjects (approximately equal numbers of male and females) 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, and will be described fully in a protocol amendment. For each cohort, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1, and subjects who remain eligible will, after a minimum 10-hour overnight fast, 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 CRU after the End of Study (EOS) procedures are completed on Day 6.

Conditions

• Enteritis Caused by Radiation (Disorder)

Interventions

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

Timeline

• Start date: 2021-03-22
• Primary completion: 2021-05-18
• Completion: 2021-09-30
• First posted: 2021-03-25
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study