Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model

NCT05933525 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IMM-124E-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled study to investigate if Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.

Conditions

Diarrhea; Travelers Diarrhea; Infectious Diarrhea

Keywords

Enterotoxigenic E.coli; Travelers diarrhea; prophylactic; ETEC; IMM-124E; Travelan

Outcome Measures

Primary Outcomes (1)

• To measure the protective efficacy of oral administration of Travelan compared to placebo against moderate-to-severe diarrhea following with E.coli (ETEC) challenge.

  The number of subjects who encounter moderate to severe diarrhea (defined as ≥4 Grade 3-5 stools in any 24-hour period post-challenge or ≥401 grams of Grade 3-5 stools in any 24-hour period post-challenge) will be recorded for the Travelan group and the placebo group. All stool samples will be collected, weighed and graded. Stool grading scale: Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal). Diarrhea (Grade 3-5 stools) severity in a 24 hour period (1g = 1ml): 1-mild (2-3 loose/liquid stool totaling \<400 g), 2-moderate (4 to 5 loose/liquid stools or \>401 to 800 g), 3-severe (6 or more loose/liquid stools totaling \>800 g).

  Monitoring for the Inpatient Study Phase, Study Days -3 to Day 8 or day of dismissal from the clinical trial facility

Secondary Outcomes (4)

• Subjects requiring oral rehydration solution and/or intravenous fluids post ETEC challenge for the Travelan group and the placebo group

  Monitoring post challenge on Study Days 1-8 or Day of dismissal from the clinical trial facility.

• Density of ETEC organisms in post-challenge stool samples at 48 hours post ETEC challenge for the Travelan group and the placebo group

  Monitoring on Study Day 3 or 48 hours post challenge

• Safety and tolerability of oral doses of Travelan compared to placebo. Measurement ofthe number of AEs graded as moderate-to-severe (Grade 2-4) for Diarrhea, fever, vomiting and other listed AEs as assessed using the CTCAE v5.0 criteria for AEs.

  Monitoring for the inpatient study phase: Study Days -3 to Day 8 or day of dismissal from the clinical trial facility.]

• Percent of subjects with severe diarrhea post ETEC challenge for the Travelan group and the placebo group

  Monitoring post challenge on Study Days 1-8 or Day of dismissal from the clinical trial facility.

Study Arms (2)

Travelan

ACTIVE COMPARATOR

IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally for 7 days.

Biological: Travelan

Placebo

PLACEBO COMPARATOR

ProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. 1200mg will be taken orally for 7 days.

Other: Placebo

Interventions

Travelan BIOLOGICAL

6 Travelan tablets (1200mg) administered orally for 7 days

Also known as: IMM-124E

Travelan

Placebo OTHER

6 tablets of placebo (1200mg) administered orally for 7 days

Also known as: ProMilk 85 milk powder

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 50 years of age, inclusive at time of screening visit.
• General good health, without significant medical illness, abnormal vital signs or physical examination findings, or clinical laboratory abnormalities, as determined by the principal investigator (PI) in consultation with the Medical Monitor and Sponsor.
• Demonstrate comprehension of the protocol procedures, requirements, and CHIM this will be evaluated by completing a multiple choice comprehension assessment (passing grade \> 70%) during screening and in the consenting process.
• Willing to participate, as evidenced by signing the informed consent document.
• Available for all planned follow-up visits.
• Negative serum pregnancy test at screening and negative serum and/or urine pregnancy test on the day of admittance to the inpatient unit for all female participants. All females must agree to use an efficacious hormonal or barrier method of birth control during the study. Efficacious methods of birth control include hormonal birth control methods (oral contraceptive pills, patches, vaginal rings, long-acting reversible contraception, surgical sterilization, condoms with spermicide, or abstinence from intercourse with a male partner. Female participants unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
• A negative Covid-19 PCR test is required on the day of admission to the unit to comply with Pharmaron's Covid-19 policy (subjects reporting to admission for Cohort 1 who test positive for COVID-19 may rescreen for Cohort 2)
• Acceptable hematology and blood chemistry levels as assessed by the PI. i.e., Serum creatinine \<1.3 mg/dL. AST, GGT, amylase, lipase, alkaline phosphatase not to exceed 1.5x upper limit of normal (ULN)
• Vital signs will be assessed in the supine position and must be within the following ranges:
• Oral body temperature between 35-37oC inclusive
• Systolic blood pressure between 90-140 mmHg inclusive
• Diastolic blood pressure between 55-90 mmHg inclusive
• Pulse rate between 45-90 bpm inclusive

You may not qualify if:

• Immunosuppressive illness or evidence of IgA deficiency (serum IgA levels outside the normal range). This includes any disease that requires immunosuppressive medication such corticosteroids, monoclonal antibodies that target key aspects of the immune system (e.g. rituximab or TNF-blockers, or any autoimmune disease).
• Positive serology results for HIV, HBsAg, or HCV antibodies, and confirmatory tests if appropriate.
• Positive urine drug screen (positive for the presence of amphetamines, barbiturates, opiates, phencyclidine, cocaine, benzodiazepines, methadone, and propoxyphene at screening and at the discretion of the study physician, with the exception of stable persons with a diagnosis of ADHD that is well-controlled with a prescribed amphetamine.
• History of alcohol abuse in the past 3 months or drug abuse in the past year
• Significant abnormalities in screening laboratory hematology, serum chemistry or electrocardiogram, as determined by the PI or PI in consultation with the Medical Monitor and Sponsor. Significant ECG abnormalities include the following:
• PR \> 220 msec
• QRS complex \> 120 msec
• QTcF \> 450 msec (male) or \>460 msec (female)
• Serum bilirubin exceeds upper limit of normal
• Nursing or lactating on the day of admittance to the inpatient unit.
• Inability to tolerate 150 ml of sodium bicarbonate buffer.
• Recent vaccination (including licensed vaccines) or receipt of an investigational product (within 30 days before challenge through 30 days following the challenge dose).
• History of diarrhea (\> 3 unformed or liquid stools over a 24-hour period) in the 2 weeks prior to the planned inpatient phase.
• Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, or loose or liquid stools other than on an occasional basis.
• Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly).

Sponsors & Collaborators

• Immuron Ltd.: lead
• United States Department of Defense: collaborator
• Naval Medical Research Center: collaborator

Study Sites (1)

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diarrhea; Dysentery

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Mohamed Al-Ibrahim, MB,ChB,FACP

  Pharmaron Clinical Pharmacology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Consenting, eligible participants will be randomized in a 1:1 ratio to receive either the test article Travelan® or placebo. Once enrolled into the study (subject meets all eligibility criteria and is selected by the investigator for inclusion in the study), subjects will be assigned a randomization number. The subject will receive the study treatment regimen assigned to the corresponding randomization number. Subjects will receive the test article/placebo in containers bearing their assigned identification numbers. This number will be linked to the randomization code list securely maintained throughout the clinical phase of the study by the designated study staff. Investigators and participants will remain blinded to group assignments until completion of the clinical phase of the trial and validation of the clinical and immunological data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 60 healthy volunteer participants will be randomized to receive Travelan investigational product or placebo. The study is a double-blind randomized study.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 6, 2023
• Study Start: May 29, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)