Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

Lumen Bioscience

Status and phase: Completed; Phase 1

Conditions: C. Diff. Infections

Treatments: Biological: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3; Biological: LMN-201 Anti-toxin B VHH-3; Biological: LMN-201 Anti-toxin B VHH-2; Biological: LMN-201 Anti-toxin B VHH-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04893239

CDI01

Details and patient eligibility

About

This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.

Enrollment: 12 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willing to participate in the clinical trial
• Able and willing to provide informed consent
• Stable ostomy (no revisions in the last 6 months)
• At least 19 years old
• Medically stable, but may be on medications for chronic conditions

Exclusion criteria

• Unable or unwilling to provide adequate informed consent
• Non-English speakers
• Clinically significant disease
• Women who are pregnant, intending to become pregnant, or breastfeeding
• Use of anti-diarrheal medicine
• Suffer gastroparesis
• Opioid use

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Cohort 1 LMN-201 Anti-toxin B VHH-1

Experimental group

Treatment:

Biological: LMN-201 Anti-toxin B VHH-1

Cohort 1 LMN-201 Anti-toxin B VHH-2

Experimental group

Treatment:

Biological: LMN-201 Anti-toxin B VHH-2

Cohort 1 LMN-201 Anti-toxin B VHH-3

Experimental group

Treatment:

Biological: LMN-201 Anti-toxin B VHH-3

Cohort 4 LMN-201 VHH 1, 2, 3

Experimental group

Treatment:

Biological: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3