HealthyPhase 1NCT04984525
Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
A Phase 1 study testing SYNB1934 and SYNB1618 in people with Healthy, run by Synlogic at 1 site in United States.
Trial summary
This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SYNB1934 and SYNB1618
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 10 Dec 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 to ≤ 64 years.
- Able and willing to voluntarily complete the informed consent process.
- Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, inpatient monitoring, follow-up visits, and compliance with all study procedures.
- Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as a condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) (as defined in Inclusion Criterion # 5) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the IMP.
- Female subjects who meet 1 of the following:
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (human chorionic gonadotropin) at Screening and a negative urine pregnancy test at baseline prior to the start of IMP and must agree to use acceptable method(s) of contraception, combined with an acceptable method of contraception for their male partner(s) (as defined in Inclusion Criterion # 4) after informed consent, throughout the study and for a minimum of 3 months after the last dose of IMP. Acceptable methods of contraception include hormonal contraception, hormonal or non-hormonal intrauterine device, bilateral tubal occlusion, complete abstinence, vasectomized partner with documented azoospermia 3 months after procedure, diaphragm with spermicide, cervical cap with spermicide, vaginal sponge with spermicide, or male or female condom with or without spermicide.
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- Premenopausal women with at least 1 of the following:
- Documented hysterectomy ii. Documented bilateral salpingectomy iii. Documented bilateral oophorectomy iv. Documented tubal ligation/occlusion v. Sexual abstinence is preferred or usual lifestyle of the subject
- Postmenopausal women (12 months or more amenorrhea verified by follicle-stimulating hormone assessment and over 45 years of age in the absence of other biological or physiological causes).
Who cannot join
- Acute or chronic medical (including COVID-19 infection), surgical, psychiatric, or social condition or laboratory abnormality that may increase subject risk associated with study participation, compromise adherence to study procedures and requirements, or may confound interpretation of study safety or PD results and, in the judgment of the investigator, would make the subject inappropriate for enrollment.
- Body mass index < 18.5 or ≥ 35 kg/m2.
- History of or current immunodeficiency disorder including human immunodeficiency virus (HIV) antibody positivity.
- Hepatitis B surface antigen positivity (subjects with hepatitis B surface antibody positivity and hepatitis B core antibody positivity are not excluded, provided that the hepatitis B surface antigen is negative).
- Hepatitis C antibody positivity, unless a hepatitis C virus ribonucleic acid test is performed, and the result is negative.
- History of febrile illness, confirmed bacteremia, or other active infection deemed clinically significant by the investigator within 30 days prior to the anticipated first dose of IMP.
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- History of (within the past month) passage of 3 or more loose stools per day, where "loose stool" is defined as a Type 6 or Type 7 on the Bristol Stool Chart.
- Inflammatory or irritable bowel disorder of any grade experienced within the previous 60 days.
- Active or past history of gastrointestinal bleeding within 60 days prior to the Screening Visit as confirmed by hospitalization-related event(s) or medical history of hematemesis or hematochezia.
- Intolerance of or allergic reaction to EcN, esomeprazole, or any of the ingredients in SYNB1934 or placebo formulations. (For subjects who may be randomized to receive SYNB1618, intolerance of or allergic reaction to any of the ingredients in the SYNB1618 formulation.)
- Any condition (e.g., celiac disease, gastrectomy, bypass surgery, ileostomy), prescription medication, or over-the-counter product that may possibly affect absorption of medications or nutrients.
- Currently taking or plans to take any type of systemic (e.g., oral or intravenous) antibiotic within 30 days prior to Day -1 through the final day of inpatient monitoring. Exception: topical antibiotics are allowed.
- Major surgery (an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity) or inpatient hospital stay within the past 3 months prior to Screening.
- Planned surgery, hospitalizations, dental work, or interventional studies between Screening and last anticipated visit.
- Taking or planning to take probiotic supplements (enriched foods excluded) within 30 days prior to Day -1 through the Safety Follow-up Period.
- Dependence on alcohol or drugs of abuse.
- Administration or ingestion of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the Screening Visit, or current enrollment in an investigational study.
- Receipt of a COVID-19 vaccine 7 days prior to the anticipated first dose of IMP or 7 days after the last dose of IMP is permitted; otherwise, COVID-19 vaccines are not permitted during study participation.
- Administration or ingestion of a PPI within 30 days prior to Day -2.
- Screening laboratory parameters (e.g., chemistry panel, hematology, coagulation) and ECG outside of the normal limits based on standard ranges, or as judged to be clinically significant by the investigator. A single repeat evaluation is acceptable.
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point Clinical Trials Center
High Point, North Carolina, 27265
About this study
Official title: A Phase 1, Dose-escalation, Placebo- and Active-Controlled Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1934 and the Effect of Concomitant Proton Pump Inhibitor Administration in Healthy Volunteers
This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.
Read the detailed description
This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB1934 within the following 2 study parts:
Part 1 is an inpatient, placebo-controlled, multiple ascending dose (MAD) study in HV male and female subjects in up to 5 dose cohorts (6 treated: 2 placebo) for 5 days of dosing to identify the maximum tolerated dose (MTD). During the second cohort an additional 6 treated subjects will be enrolled; all treated subjects in Cohort 2 will complete a second treatment period with SYNB1618 in a cross-over design.
Part 2 is an open-label, randomized sequence, crossover study of SYNB1934 that will be initiated after determination and selection of a well-tolerated dose in Part 1. Subjects will receive treatment with SYNB1934 with a proton pump inhibitor (PPI), will complete a treatment washout period, and receive SYNB1934 treatment without a PPI. Initially 16 HV male and female subjects will be enrolled with the option of expanding Part 2 up to 60 HV subjects.
- Conditions
- Healthy
- Being tested
- SYNB1934, SYNB1618
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNB1934Drug
SYNB1934 is formulated as a nonsterile solution intended for oral administration
SYNB1618Drug
SYNB1618 is formulated as a nonsterile solution intended for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 MAD HV: SYNB1934 (3 x 10^11 live cells) | Experimental | HV subjects receive SYNB1934 (3 x 10^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934 |
| Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells) | Experimental | HV subjects receive SYNB1934 (6 x 10^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 7-day washout period HV subjects receive SYNB1618 (6 x 10^11 live cells), at least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934; Drug: SYNB1618 |
| Part 1 Cohort 3 MAD HV: SYNB1934 (1 x 10^12 live cells) | Experimental | HV subjects receive SYNB1934 (1 x 10^12 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934 |
| Part 1 Cohort 4 MAD HV: SYNB1934 (optional) | Experimental | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934 |
| Part 1 Cohort 5 MAD HV: SYNB1934 (optional) | Experimental | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934 |
| Part 2 Crossover with PPI vs No PII | Experimental | HV subjects receive SYNB1934 (at or below the MTD from Part 1) with PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 14-day washout period HV subjects receive SYNB1934 (at or below the MTD from Part 1) without PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Receives: Drug: SYNB1934 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment-Emergent Adverse Events
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period.
AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after the first dose of study treatment. TEAEs are considered treatment-related if relationship to study drug is possibly related, probably related, or definitely related.
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start2 Jul 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synlogic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984525
- Sponsor's protocol ID
- SYNB1934-CP-001
- Status last verified
- May 2022
- First submitted
- 21 Jul 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-escalation, Placebo- and Active-Controlled Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1934 and the Effect of Concomitant Proton Pump Inhibitor Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04984525
- Acronym / sponsor ID
- SYNB1934-CP-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- SynlogicIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 30 Jul 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 Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.
Detailed description
This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB1934 within the following 2 study parts:
Part 1 is an inpatient, placebo-controlled, multiple ascending dose (MAD) study in HV male and female subjects in up to 5 dose cohorts (6 treated: 2 placebo) for 5 days of dosing to identify the maximum tolerated dose (MTD). During the second cohort an additional 6 treated subjects will be enrolled; all treated subjects in Cohort 2 will complete a second treatment period with SYNB1618 in a cross-over design.
Part 2 is an open-label, randomized sequence, crossover study of SYNB1934 that will be initiated after determination and selection of a well-tolerated dose in Part 1. Subjects will receive treatment with SYNB1934 with a proton pump inhibitor (PPI), will complete a treatment washout period, and receive SYNB1934 treatment without a PPI. Initially 16 HV male and female subjects will be enrolled with the option of expanding Part 2 up to 60 HV subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 MAD HV: SYNB1934 (3 x 10^11 live cells) | Experimental | Drug: SYNB1934HV subjects receive SYNB1934 (3 x 10^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells) | Experimental | Drug: SYNB1934, Drug: SYNB1618HV subjects receive SYNB1934 (6 x 10^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 7-day washout period HV subjects receive SYNB1618 (6 x 10^11 live cells), at least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 3 MAD HV: SYNB1934 (1 x 10^12 live cells) | Experimental | Drug: SYNB1934HV subjects receive SYNB1934 (1 x 10^12 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 4 MAD HV: SYNB1934 (optional) | Experimental | Drug: SYNB1934HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 5 MAD HV: SYNB1934 (optional) | Experimental | Drug: SYNB1934HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 2 Crossover with PPI vs No PII | Experimental | Drug: SYNB1934HV subjects receive SYNB1934 (at or below the MTD from Part 1) with PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 14-day washout period HV subjects receive SYNB1934 (at or below the MTD from Part 1) without PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age ≥ 18 to ≤ 64 years.
- Able and willing to voluntarily complete the informed consent process.
- Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, inpatient monitoring, follow-up visits, and compliance with all study procedures.
- Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as a condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) (as defined in Inclusion Criterion # 5) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the IMP.
- Female subjects who meet 1 of the following:
Key exclusion criteria (20 listed)
- Acute or chronic medical (including COVID-19 infection), surgical, psychiatric, or social condition or laboratory abnormality that may increase subject risk associated with study participation, compromise adherence to study procedures and requirements, or may confound interpretation of study safety or PD results and, in the judgment of the investigator, would make the subject inappropriate for enrollment.
- Body mass index < 18.5 or ≥ 35 kg/m2.
- History of or current immunodeficiency disorder including human immunodeficiency virus (HIV) antibody positivity.
- Hepatitis B surface antigen positivity (subjects with hepatitis B surface antibody positivity and hepatitis B core antibody positivity are not excluded, provided that the hepatitis B surface antigen is negative).
- Hepatitis C antibody positivity, unless a hepatitis C virus ribonucleic acid test is performed, and the result is negative.
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 |
|---|---|---|
| SYNB1934SYNB1934 is formulated as a nonsterile solution intended for oral administration | Drug | Part 1 Cohort 1 MAD HV: SYNB1934 (3 x 10^11 live cells), Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells), Part 1 Cohort 3 MAD HV: SYNB1934 (1 x 10^12 live cells), Part 1 Cohort 4 MAD HV: SYNB1934 (optional), Part 1 Cohort 5 MAD HV: SYNB1934 (optional), Part 2 Crossover with PPI vs No PII |
| SYNB1618SYNB1618 is formulated as a nonsterile solution intended for oral administration | Drug | Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells) |
Primary outcome
Number of Subjects With Treatment-Emergent Adverse Events
Time frame: 70 days
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after the first dose of study treatment. TEAEs are considered treatment-related if relationship to study drug is possibly related, probably related, or definitely related.
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 18 May 2022.
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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.
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 SYNB1934 and SYNB1618 in people with Healthy, run by Synlogic 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 9 inclusion and 20 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 18 May 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?
Number of Subjects With Treatment-Emergent Adverse Events (time frame: 70 days). 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 18 May 2022.