Enteritis Caused by Radiation (Disorder)Phase 1NCT04815993
Pharmacokinetics, Safety, and Tolerability of SYN-020
A Phase 1 study testing SYN-020 delayed release capsule in people with Enteritis Caused by Radiation (Disorder), run by Theriva Biologics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteritis Caused by Radiation (Disorder)
- What is being tested?
- SYN-020 delayed release capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 30 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 has used any medication (prescription or non-prescription) or herbal supplement, other than prescription hormone replacement therapy (eg, thyroid, testosterone, estrogen) or contraception methods described in Inclusion Criterion #6, within 21 days before Day -1.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Single Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN-020 Delayed Release Capsules in Healthy Subjects
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.
Read the 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)
- Being tested
- SYN-020 delayed release capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN-020 delayed release capsuleDrug
Also called Intestinal Alkaline Phosphatase
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
| Study group | Role | What they receive |
|---|---|---|
| SYN-020, 5 mg | Experimental | 6 subjects to receive a single 5 mg dose of SYN-020 Receives: Drug: SYN-020 delayed release capsule |
| SYN-020, 15 mg | Experimental | 6 subjects to receive a single 15 mg dose of SYN-020 Receives: Drug: SYN-020 delayed release capsule |
| SYN-020, 45 mg | Experimental | 6 subjects to receive a single 45 mg dose of SYN-020 Receives: Drug: SYN-020 delayed release capsule |
| SYN-020, 150 mg | Experimental | 6 subjects to receive a single 150 mg dose of SYN-020 Receives: Drug: SYN-020 delayed release capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
SYN-020 systemic absorption
Analysis of SYN-020 level present in blood
Measured: Daily Day 1 through Day 5
SYN-020 presence in feces
Analysis of SYN-020 level present in feces
Measured: Daily Day -1 through Day 6
Secondary outcomes (5)
Percentage of Participants with Changes in Clinical Laboratory Testing
Hematology, clinical chemistry, urinalysis, virus serology, drug screen, alcohol screen, pregnancy test, postmenopausal screen
Measured: Day -1, Day 2, Day 6
Number of Participants With Changes in Physical exam
Complete and abbreviated physical examinations will be performed
Measured: Day 1 and Day 6
Number of Participants with Changes in Vital Signs
Blood pressure, pulse rate, respiratory rate, oral temperature
Measured: Daily Day -1 through Day 6
Number of Participants with Changes in Electrocardiograms
12-lead ECG, P-wave, QRS-complex, QT-interval
Measured: Day -1, Day 1, Day 2, Day 6
Immunogenicity testing
Measurement of anti-drug antibodies by ELISA
Measured: Day 1, Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Mar 2021
- Primary completion18 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteritis Caused by Radiation (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- single ascending dose
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theriva Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815993
- Sponsor's protocol ID
- SB-1-020-001
- Status last verified
- Nov 2024
- First submitted
- 12 Mar 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN-020 Delayed Release Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04815993
- Acronym / sponsor ID
- SB-1-020-001
- Conditions
- Enteritis Caused by Radiation (Disorder)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Theriva Biologics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- single ascending dose
| Arm | Type | Receives |
|---|---|---|
| SYN-020, 5 mg | Experimental | Drug: SYN-020 delayed release capsule6 subjects to receive a single 5 mg dose of SYN-020 |
| SYN-020, 15 mg | Experimental | Drug: SYN-020 delayed release capsule6 subjects to receive a single 15 mg dose of SYN-020 |
| SYN-020, 45 mg | Experimental | Drug: SYN-020 delayed release capsule6 subjects to receive a single 45 mg dose of SYN-020 |
| SYN-020, 150 mg | Experimental | Drug: SYN-020 delayed release capsule6 subjects to receive a single 150 mg dose of SYN-020 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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 has used any medication (prescription or non-prescription) or herbal supplement, other than prescription hormone replacement therapy (eg, thyroid, testosterone, estrogen) or contraception methods described in Inclusion Criterion #6, within 21 days before Day -1.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYN-020 delayed release capsuleAlso: Intestinal Alkaline PhosphataseSYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets. | Drug | SYN-020, 15 mg, SYN-020, 150 mg, SYN-020, 45 mg, SYN-020, 5 mg |
Primary outcome
SYN-020 systemic absorption
Time frame: Daily Day 1 through Day 5
Analysis of SYN-020 level present in blood
SYN-020 presence in feces
Time frame: Daily Day -1 through Day 6
Analysis of SYN-020 level present in feces
5 secondary outcomes
Percentage of Participants with Changes in Clinical Laboratory Testing
Time frame: Day -1, Day 2, Day 6
Number of Participants With Changes in Physical exam
Time frame: Day 1 and Day 6
Number of Participants with Changes in Vital Signs
Time frame: Daily Day -1 through Day 6
Number of Participants with Changes in Electrocardiograms
Time frame: Day -1, Day 1, Day 2, Day 6
Immunogenicity testing
Time frame: Day 1, Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYN-020 delayed release capsule in people with Enteritis Caused by Radiation (Disorder), run by Theriva Biologics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SYN-020 systemic absorption (time frame: Daily Day 1 through Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.