Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

NCT06193408 | Completed Phase 2 Results DMC

• 1 other identifier: PR-23089
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens

Conditions

Cholera

Outcome Measures

Primary Outcomes (1)

• Stool Output Volume During Treatment Period.

  Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.

  Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).

Secondary Outcomes (6)

• Duration of Stool Output in Excess of 200 ml/Hour

  Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).

• Number of Unscheduled IV Rehydration Episodes Per Treatment

  Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).

• Volume of IV Rehydration, ml/kg

  Volume of administered IV rehydration solution was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).

• Time Until Last Liquid Stool

  Liquid and solid stool output was measured by trained trial personnel and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).

• Duration of Stool Output in Excess of 400 mL/Hour

  Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).

Study Arms (2)

VR-AD-1005

EXPERIMENTAL

Drug: VR-AD-1005

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VR-AD-1005 DRUG

oral capsule

VR-AD-1005

Placebo DRUG

oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Adults, both genders aged 18-65 years.
• Acute watery diarrhea (defined as passage of three or more liquid stools within the 24 hours before admission) with severe dehydration on arrival.
• Detection of V. cholerae by rapid diagnostic assay (e.g. dark field microscopy).

You may not qualify if:

• Known or suspected hypersensitivity to trial product(s) or related products.
• Subjects with passage of bloody stools or muco-purulent stools.
• Subjects with chronic diarrhea (\>4 weeks of Diarrhea).
• Clinically significant concomitant systemic disease (i.e. cardiovascular diseases including heart failure, acute kidney injury, sepsis or life-threatening malignant cancer).
• Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
• History of receiving antimicrobial or antidiarrheal drugs within 6 hours prior to admission.
• Positive urine pregnancy test for all female patients
• Failure to obtain informed consent.
• Failure to definitively diagnose cholera via culture or RT-PCR

Sponsors & Collaborators

• Hunazine Biotech S.L.: lead

Study Sites (1)

Icddr,b

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

The limitations included the variability in clinical course among patients, the reliance on a single high-resource center, the relatively small sample size. These constrained the ability to demonstrate statistical significance across all secondary endpoints. Moreover, oral dosing carries inherent limitations in patients with impaired consciousness or vomiting. IP dose was limited by safety concerns as first in-human study. Future studies should examine higher dosing options.

Results Point of Contact

• Title: Dmitry Kravtsov MD, Chief Scientific Officer
• Organization: Hunazine Biotech S.L.

dmitry.kravtsov@hunazinebiotech.com

+12038368424

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: randomized, placebo-controlled, double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 5, 2024
• Study Start: February 11, 2024
• Primary Completion: August 11, 2024
• Study Completion: September 8, 2024
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)