Enteritis Caused by RadiationPhase 1NCT05045833
Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020
A Phase 1 study testing SYN-020 Delayed Release Capsule in people with Enteritis Caused by Radiation, run by Theriva Biologics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enteritis Caused by Radiation
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 21 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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, at least 18 years of age.
- 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.
- 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.
- 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 ICF to at least either 90 days (males) or 30 days (females) after the last study drug dose by following the procedures below.
Show all 20Show fewer
- 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
- If female, subject has a negative serum pregnancy test at Screening and upon 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) 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.
- 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 CRU discharge.
- 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.
Show all 11Show fewer
- Subject has donated more than 500 mL blood during the 3-month period before CRU admission.
- Subject has known intolerance of study drug or 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 or a previous SYN 020 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 Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 Delayed Release Capsules in Healthy Subjects
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.
Read the detailed description
Randomization to treatment will be stratified by sex, with equal numbers of males and females receiving each treatment in each cohort. Up to 5 ascending-dose cohorts of 8 subjects each will be enrolled, and all cohorts will be conducted as planned or until the safety data do not support further escalation. SYN-020 (or placebo) will be administered every 12 hours for 14 consecutive days at escalating doses of 5, 15, 45, and 75 mg in Cohorts 1 through 4, and at a dose not to exceed 75 mg in Cohort 5.
Subjects will be screened within 28 days before admission to the clinical research unit (CRU). For each cohort, eligible subjects will be admitted to the CRU on Day -1, and subjects who remain eligible will receive the first dose of study drug in the morning (AM) of Day 1. Subjects will receive study drug every 12 hours for 14 consecutive days. No restriction in food or fluids is required around dosing for any dose other than the AM dose on Days 1 and 14. Subjects will also fast overnight before blood samples are collected for clinical laboratory and/or PD tests on Days 2, 6, 8, 10, 14, and at the follow-up visit on Day 35. A standard Western diet appropriate for a Phase 1 study will be provided at approximately the same times each day during confinement, with each cohort receiving the same meals.
Subjects will be discharged from the CRU after the End of Study (EOS) procedures are completed in the AM on Day 15 and will return to the CRU for a follow-up visit on Day 35.
For PK assessment, blood samples (primarily on Days 1 and 14) and feces (pre-dose and over selected 48 hour time intervals) will be collected for analysis of SYN 020 concentrations.
For PD assessment, blood will be collected and analyzed (or stored for future analysis) for at least 1 of the exploratory endpoints. Fecal samples for PD assessment will be taken from the feces collected for PK assessment. These investigations will explore potential biomarkers for future SYN 020 indications and will be strictly and directly related to the pharmacology of SYN 020. While gastrointestinal microbiome/metabolome analyses include genotyping of the gut bacteria, no human genotyping will be performed.
Safety and tolerability will be monitored throughout the study. Safety assessments will include clinical laboratory tests, vital signs, 12-lead ECGs, physical examinations, monitoring for AEs, and ADA testing. Adverse event data will be collected from the time of informed consent through the follow-up visit at Day 35 or until the AE resolves or becomes stable.
- Conditions
- Enteritis Caused by Radiation
- 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
Oral administration (by mouth)
| Study group | Role | What they receive |
|---|---|---|
| 5 mg SYN-020 | Experimental | 1 x 5 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo Receives: Drug: SYN-020 Delayed Release Capsule |
| 15 mg SYN-020 | Experimental | 1 x 15 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo Receives: Drug: SYN-020 Delayed Release Capsule |
| 45 mg SYN-020 | Experimental | 3 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo Receives: Drug: SYN-020 Delayed Release Capsule |
| 75 mg SYN-020 | Experimental | 5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo Receives: Drug: SYN-020 Delayed Release Capsule |
| ≤ 75 mg SYN-020 (new formulation) | Experimental | ≤ 5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo 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: Day 1 to Day 15
SYN-020 presence in feces
Analysis of SYN-020 level present in feces
Measured: Day -1 to Day 14
Secondary outcomes (1)
Monitoring for Safety and Tolerability
Adverse Events, CTCAE v5.0
Measured: Day 1 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start18 Oct 2021
- Primary completion22 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteritis Caused by RadiationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multiple Ascending Dose Escalation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theriva Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045833
- Sponsor's protocol ID
- SB-1-020-002
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 21 Apr 2022
- Results posted
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 Delayed Release Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05045833
- Acronym / sponsor ID
- SB-1-020-002
- Conditions
- Enteritis Caused by Radiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Theriva Biologics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 16 Sep 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, 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.
Detailed description
Randomization to treatment will be stratified by sex, with equal numbers of males and females receiving each treatment in each cohort. Up to 5 ascending-dose cohorts of 8 subjects each will be enrolled, and all cohorts will be conducted as planned or until the safety data do not support further escalation. SYN-020 (or placebo) will be administered every 12 hours for 14 consecutive days at escalating doses of 5, 15, 45, and 75 mg in Cohorts 1 through 4, and at a dose not to exceed 75 mg in Cohort 5.
Subjects will be screened within 28 days before admission to the clinical research unit (CRU). For each cohort, eligible subjects will be admitted to the CRU on Day -1, and subjects who remain eligible will receive the first dose of study drug in the morning (AM) of Day 1. Subjects will receive study drug every 12 hours for 14 consecutive days. No restriction in food or fluids is required around dosing for any dose other than the AM dose on Days 1 and 14. Subjects will also fast overnight before blood samples are collected for clinical laboratory and/or PD tests on Days 2, 6, 8, 10, 14, and at the follow-up visit on Day 35. A standard Western diet appropriate for a Phase 1 study will be provided at approximately the same times each day during confinement, with each cohort receiving the same meals.
Subjects will be discharged from the CRU after the End of Study (EOS) procedures are completed in the AM on Day 15 and will return to the CRU for a follow-up visit on Day 35.
For PK assessment, blood samples (primarily on Days 1 and 14) and feces (pre-dose and over selected 48 hour time intervals) will be collected for analysis of SYN 020 concentrations.
For PD assessment, blood will be collected and analyzed (or stored for future analysis) for at least 1 of the exploratory endpoints. Fecal samples for PD assessment will be taken from the feces collected for PK assessment. These investigations will explore potential biomarkers for future SYN 020 indications and will be strictly and directly related to the pharmacology of SYN 020. While gastrointestinal microbiome/metabolome analyses include genotyping of the gut bacteria, no human genotyping will be performed.
Safety and tolerability will be monitored throughout the study. Safety assessments will include clinical laboratory tests, vital signs, 12-lead ECGs, physical examinations, monitoring for AEs, and ADA testing. Adverse event data will be collected from the time of informed consent through the follow-up visit at Day 35 or until the AE resolves or becomes stable.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Multiple Ascending Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| 5 mg SYN-020 | Experimental | Drug: SYN-020 Delayed Release Capsule1 x 5 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 15 mg SYN-020 | Experimental | Drug: SYN-020 Delayed Release Capsule1 x 15 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 45 mg SYN-020 | Experimental | Drug: SYN-020 Delayed Release Capsule3 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 75 mg SYN-020 | Experimental | Drug: SYN-020 Delayed Release Capsule5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| ≤ 75 mg SYN-020 (new formulation) | Experimental | Drug: SYN-020 Delayed Release Capsule≤ 5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 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, at least 18 years of age.
- 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.
- 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.
- 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) 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.
- 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 CRU discharge.
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 CapsuleOral administration (by mouth) | Drug | 15 mg SYN-020, 45 mg SYN-020, 5 mg SYN-020, 75 mg SYN-020, ≤ 75 mg SYN-020 (new formulation) |
Primary outcome
SYN-020 systemic absorption
Time frame: Day 1 to Day 15
Analysis of SYN-020 level present in blood
SYN-020 presence in feces
Time frame: Day -1 to Day 14
Analysis of SYN-020 level present in feces
1 secondary outcome
Monitoring for Safety and Tolerability
Time frame: Day 1 to Day 35
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 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Enteritis Caused by Radiation
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
Not yet recruitingObservational study
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
Radiation Enteritis
Not yet recruitingPhase 2
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Acute Radiation Enteritis
RecruitingPhase 2
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.
Radiation Enteritis
Active, not recruitingPhase 1/2
CMTS0515-auWMT for Radiation Enteritis
Radiation Enteritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 20 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 Apr 2022. 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: Day 1 to Day 15). 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 Apr 2022.