Clinical trial NCT04236778: First-in-human Study of VE303 in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Vedanta Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Key Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: Safety of VE303 measured by incidence adverse events (AEs)
timeFrame: 12 months post-dose
measure: Tolerability of VE303 using modified PROMIS questionnaire (v1.0)
timeFrame: 12 months post-dose
Secondary outcomes:
measure: Evaluate the colonization of the intestinal microbiota with VE303 component bacteria
timeFrame: 12 months post-dose
measure: Evaluate the changes in the intestinal microbiota due to VE303 dosing.
timeFrame: 12 months post-dose
measure: Evaluate the metabolomic changes in stool due to VE303 dosing.
timeFrame: 12 months post-dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC
state: Maryland
Study officials:
References: