Healthy VolunteersPhase 1NCT04236778
First-in-human Study of VE303 in Healthy Adult Volunteers
A Phase 1 study testing VE303 and Oral Vancomycin in people with Healthy Volunteers, run by Vedanta Biosciences, Inc. at 1 site in United States.
Trial summary
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VE303 and Oral Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 11 Mar 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are judged to be in general good health
- Body mass index between 18.5 and 30 kg/m2
- Women either of non-child bearing potential or using a highly effective form of contraception
- Men using a highly effective method of contraception
Who cannot join
- Past or present clinically significant diseases that may affect the outcome of the study
- Taking any medications, herbal preparations, or natural substances, live bacteria products, or food that impacts or alter GI flora
- Use of proton pump inhibitors or other short or long acting antacid medications
- Taking or has received an investigation drug or treatment within 60 days of inpatient admission
- Known allergies to involved study drugs
- Chronic constipation or diarrhea
- History of or active IBD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a/1b, First-in-human, Open-label Study of Escalating Doses of VE303 in Healthy Adult Volunteers With or Without Vancomycin Pre-treatment to Evaluate Safety, Dosing, and Pharmacodynamics
This study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.
Read the detailed description
VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.
- Conditions
- Healthy Volunteers
- Being tested
- VE303, Oral Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VE303Drug
The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
Oral VancomycinDrug
Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 received oral vancomycin followed by a single dose of VE303. Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 2 | Experimental | Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303. Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 3 | Experimental | Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303. Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 4 | Experimental | Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303. Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 5 | Experimental | Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303 Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 6 | Experimental | Cohort 6 received 21 days of 10 doses daily of VE303 Receives: Drug: VE303 |
| Cohort 7 | Experimental | Cohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 8 | Experimental | Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days Receives: Drug: VE303; Drug: Oral Vancomycin |
| Cohort 9 | Experimental | Cohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days Receives: Drug: VE303; Drug: Oral Vancomycin |
| Vancomycin only | Placebo comparator | This cohort only received oral vancomycin. Receives: Drug: Oral Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of VE303 measured by incidence adverse events (AEs)
Measured in terms of incidence of AEs according to CTCAE V4.0
Measured: 12 months post-dose
Tolerability of VE303 using modified PROMIS questionnaire (v1.0)
Characterized the highest well tolerated dose regimen of VE303 using modified PROMIS questionnaire (v1.0)
Measured: 12 months post-dose
Secondary outcomes (3)
Evaluate the colonization of the intestinal microbiota with VE303 component bacteria
Measurement of VE303 strain colonization in stool samples was performed using a metagenomic sequencing-based bioinformatic approach. A strain-specific marker panel was employed to characterize the relative abundance of VE303 strains in the intestinal microbiota.
Measured: 12 months post-dose
Evaluate the changes in the intestinal microbiota due to VE303 dosing.
Measurement of intestinal microbiota due to VE303 dosing was performed using metagenomic sequencing- and metabolomic analysis-based approaches. Thus, focusing on taxonomic and functional changes occurring in the gut.
Measured: 12 months post-dose
Evaluate the metabolomic changes in stool due to VE303 dosing.
Quantified changes in pool of metabolite levels (bile acids and short-chain fatty acids) from stool samples
Measured: 12 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start28 Nov 2017
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This Phase 1a/1b, first-in-human, open-label, single-center, dose-escalation study will evaluate the safety and microbiota changes induced by ingestion of VE303 following administration of oral vancomycin and VE303 administered without vancomycin pre-treatment in healthy adult subjects. Approximately 48 subjects are anticipated for enrollment, unless intermediate cohorts are required, in which case, up to an additional 18 subjects (for a total of approximately 66 subjects) may be enrolled.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedanta Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236778
- Sponsor's protocol ID
- VE303-01
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, First-in-human, Open-label Study of Escalating Doses of VE303 in Healthy Adult Volunteers With or Without Vancomycin Pre-treatment to Evaluate Safety, Dosing, and Pharmacodynamics
- ClinicalTrials.gov ID
- NCT04236778
- Acronym / sponsor ID
- VE303-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vedanta Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 22 Jan 2020 (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 study was designed to evaluate safety and tolerability of a range of doses of VE303 in healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administration of antibiotics followed by a course of VE303.
Detailed description
VE303 is a rationally-defined bacterial consortium candidate being developed for the prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human commensal bacteria strains selected for their ability to provide colonization resistance to C. difficile and manufactured under GMP conditions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- This Phase 1a/1b, first-in-human, open-label, single-center, dose-escalation study will evaluate the safety and microbiota changes induced by ingestion of VE303 following administration of oral vancomycin and VE303 administered without vancomycin pre-treatment in healthy adult subjects. Approximately 48 subjects are anticipated for enrollment, unless intermediate cohorts are required, in which case, up to an additional 18 subjects (for a total of approximately 66 subjects) may be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 1 received oral vancomycin followed by a single dose of VE303. |
| Cohort 2 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 2 received oral vancomycin followed by a single day of 5 doses of VE303. |
| Cohort 3 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 3 received oral vancomycin followed by a single day of 10 doses of VE303. |
| Cohort 4 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303. |
| Cohort 5 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303 |
| Cohort 6 | Experimental | Drug: VE303Cohort 6 received 21 days of 10 doses daily of VE303 |
| Cohort 7 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 7 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Cohort 8 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Cohort 9 | Experimental | Drug: VE303, Drug: Oral VancomycinCohort 8 received oral vancomycin followed by 10 doses of VE303 daily for 2 days, followed by 2 doses of VE303 daily for 3 days |
| Vancomycin only | Placebo comparator | Drug: Oral VancomycinThis cohort only received oral vancomycin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who are judged to be in general good health
- Body mass index between 18.5 and 30 kg/m2
- Women either of non-child bearing potential or using a highly effective form of contraception
- Men using a highly effective method of contraception
Key exclusion criteria (7 listed)
- Past or present clinically significant diseases that may affect the outcome of the study
- Taking any medications, herbal preparations, or natural substances, live bacteria products, or food that impacts or alter GI flora
- Use of proton pump inhibitors or other short or long acting antacid medications
- Taking or has received an investigation drug or treatment within 60 days of inpatient admission
- Known allergies to involved study drugs
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 |
|---|---|---|
| VE303The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| Oral VancomycinVancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 7, Cohort 8, Cohort 9, Vancomycin only |
Primary outcome
Safety of VE303 measured by incidence adverse events (AEs)
Time frame: 12 months post-dose
Measured in terms of incidence of AEs according to CTCAE V4.0
Tolerability of VE303 using modified PROMIS questionnaire (v1.0)
Time frame: 12 months post-dose
Characterized the highest well tolerated dose regimen of VE303 using modified PROMIS questionnaire (v1.0)
3 secondary outcomes
Evaluate the colonization of the intestinal microbiota with VE303 component bacteria
Time frame: 12 months post-dose
Evaluate the changes in the intestinal microbiota due to VE303 dosing.
Time frame: 12 months post-dose
Evaluate the metabolomic changes in stool due to VE303 dosing.
Time frame: 12 months post-dose
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 VE303 and Oral Vancomycin in people with Healthy Volunteers, run by Vedanta Biosciences, 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 4 inclusion and 7 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 27 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Safety of VE303 measured by incidence adverse events (AEs) (time frame: 12 months post-dose). 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 27 Jan 2020.