First-in-human Study of VE303 in Healthy Adult Volunteers

Vedanta Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: VE303; Drug: Oral Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04236778

VE303-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

39 participants in 10 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Cohort 1 received oral vancomycin followed by a single dose of VE303.

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 2

Experimental group

Description:

Cohort 2 received oral vancomycin followed by a single day of 5 doses of VE303.

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 3

Experimental group

Description:

Cohort 3 received oral vancomycin followed by a single day of 10 doses of VE303.

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 4

Experimental group

Description:

Cohort 4 received oral vancomycin followed by 5 days of 10 doses daily of VE303.

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 5

Experimental group

Description:

Cohort 5 received oral vancomycin followed by 14 days of 10 capsules daily of VE303

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 6

Experimental group

Description:

Cohort 6 received 21 days of 10 doses daily of VE303

Treatment:

Drug: VE303

Cohort 7

Experimental group

Description:

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

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 8

Experimental group

Description:

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

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Cohort 9

Experimental group

Description:

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

Treatment:

Drug: VE303

Drug: Oral Vancomycin

Vancomycin only

Placebo Comparator group

Description:

This cohort only received oral vancomycin.

Treatment:

Drug: Oral Vancomycin