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CompletedNCT06193408Updated Jun 2, 2026Results posted

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

A Phase 2 interventional study of VR-AD-1005 and Placebo in Cholera, sponsored by Hunazine Biotech S.L.. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Hunazine Biotech S.L. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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

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Conditions studied

  • Cholera

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03

In context

Cholera

83 studies on the registry are indexed under Cholera; 16 are open to participants now.

This study's enrollment of 150 is below the median of 262 across 72 interventional studies indexed under Cholera.

Browse Cholera studies →

Lead sponsor

This is the only study on the registry with Hunazine Biotech S.L. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed .
  • 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).

Exclusion criteria

Exclusion Criteria:

  • Known or suspected 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).
  • 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 .
  • Failure to definitively diagnose cholera via culture or RT-PCR
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    VR-AD-1005

    Drug: VR-AD-1005

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugVR-AD-1005

    oral capsule

  • DrugPlacebo

    oral capsule

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What researchers measure

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.

    Time frame: 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

  1. Duration of Stool Output in Excess of 200 ml/Hour

    For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 200ml/hour was calculated for each participant and compared for control and study intervention groups.

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

  2. Number of Unscheduled IV Rehydration Episodes Per Treatment

    Average number of unscheduled IV rehydration episodes per participant per study arm.

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

  3. Volume of IV Rehydration, ml/kg

    Average volume of IV rehydration per subject per treatment arm was calculated as aggregate per time period. Data were analyzed for three time periods, namely 0-12 hours; 0-24 hours; and the entire duration of treatment. For each period, mean volume of the infusion was calculated and expressed in ml/kg body weight.

    Time frame: 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).

  4. Time Until Last Liquid Stool

    Diarrhea duration is measured from the first dose of study drug to resolution. Time (hours) from start of treatment until the last liquid stool was determined for each participant. Data were extracted from individual stool charts, and time-to-criterion was analyzed using log-rank statistics between the Treatment and the Comparator groups.

    Time frame: 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).

  5. Duration of Stool Output in Excess of 400 mL/Hour

    For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 400ml/hour was calculated for each participant and compared for control and study intervention groups.

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

  6. Participants With at Least One Adverse Event

    Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period.

    Time frame: From enrollment until the end of follow-up, up to 28 days

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Results

Posted Mar 12, 2026
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.

Participant flow

This study recruited 150 participants in total, meeting the inclusion criteria, of which 75 participants were double-blindly assigned to the Active Arm and 75 participants were assigned to the Placebo Arm.

Participant flow — Overall Study
MilestoneVR-AD-1005Placebo
Started7575
Completed7072
Not completed53

Outcome measures

PrimaryStool Output Volume During Treatment Period.

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

Time frame:
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.).
Reported as:
Mean · ml/kg·h-1
Stool Output Volume During Treatment Period.
ml/kg·h-1VR-AD-1005Placebo
Hour 19.82 (8.46 to 11.19)9.31 (7.89 to 10.72)
Hour 65.69 (4.81 to 6.56)7.29 (6.24 to 8.35)
Hour 85.32 (4.49 to 6.15)7.93 (6.62 to 9.24)
Hour 104.56 (3.9 to 5.2)5.88 (4.86 to 6.91)
Hour 113.72 (3.03 to 4.41)5.19 (4.29 to 6.09)
Hour 221.44 (1.01 to 1.87)2.93 (2.23 to 3.64)
Hour 231.30 (0.9 to 1.7)2.12 (1.58 to 2.66)
Hour 260.71 (0.39 to 1.04)1.59 (0.88 to 2.3)
Statistical analysis
  • VR-AD-1005 vs Placebo · t-test, 2 sided · p = 0.003 (Stool volume was measured continuously during the study for every participant. Stool output data expressed as ml/kg·h-1 are presented in the table below. Data were analyzed using Student's t-test (two-tailed, unpaired).) · Mean difference (net): -1.49 · 95% CI -2.32 to -0.66The value for mean difference (Net) was estimated as Treatment - Comparator.
SecondaryDuration of Stool Output in Excess of 200 ml/Hour

For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 200ml/hour was calculated for each participant and compared for control and study intervention groups.

Time frame:
Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Reported as:
Median · Time until threshold, hours
Duration of Stool Output in Excess of 200 ml/Hour
Time until threshold, hoursVR-AD-1005Placebo
Duration of Stool Output in Excess of 200 ml/Hour10 ± 2287.515 (9 to 15)
Statistical analysis
  • VR-AD-1005 vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.05
SecondaryNumber of Unscheduled IV Rehydration Episodes Per Treatment

Average number of unscheduled IV rehydration episodes per participant per study arm.

Time frame:
Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Reported as:
Mean · episode
Number of Unscheduled IV Rehydration Episodes Per Treatment
episodeVR-AD-1005Placebo
Number of Unscheduled IV Rehydration Episodes Per Treatment0.93 (0.71 to 1.16)1.11 (0.83 to 1.39)
SecondaryVolume of IV Rehydration, ml/kg

Average volume of IV rehydration per subject per treatment arm was calculated as aggregate per time period. Data were analyzed for three time periods, namely 0-12 hours; 0-24 hours; and the entire duration of treatment. For each period, mean volume of the infusion was calculated and expressed in ml/kg body weight.

Time frame:
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).
Reported as:
Mean · ml/kg
Volume of IV Rehydration, ml/kg
ml/kgVR-AD-1005Placeo
0-12 hours period30.8 (24.7 to 37.1)51 (44.1 to 57.9)
0-24 hours period40.5 (33 to 48.1)57 (48.6 to 65.3)
Total over the entire treatment period41.1 (33.6 to 48.7)57 (48.6 to 65.3)
SecondaryTime Until Last Liquid Stool

Diarrhea duration is measured from the first dose of study drug to resolution. Time (hours) from start of treatment until the last liquid stool was determined for each participant. Data were extracted from individual stool charts, and time-to-criterion was analyzed using log-rank statistics between the Treatment and the Comparator groups.

Time frame:
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).
Reported as:
Median · Time until threshold, hours
Time Until Last Liquid Stool
Time until threshold, hoursVR-AD-1005Placebo
Time Until Last Liquid Stool27 (25 to 29)28 (26 to 30)
Statistical analysis
  • VR-AD-1005 vs Placebo · Log Rank · p = 0.045 · Hazard ratio (hr): 1.436 · 95% CI 1.008 to 2.046Log-rank (Mantel-Cox) was used to calculate p-value. Hazard Ratio (Mantel-Haenszel) was used to estimate the medians and 95% confidence intervals (as A/B).
SecondaryDuration of Stool Output in Excess of 400 mL/Hour

For analysis, individual stool charts were used to calculate stool output per patient per hour and express it as stool volume in ml/hour. Duration of time during treatment when stool output was in excess of 400ml/hour was calculated for each participant and compared for control and study intervention groups.

Time frame:
Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).
Reported as:
Median · Time until threshold, hours
Duration of Stool Output in Excess of 400 mL/Hour
Time until threshold, hoursVR-AD-1005Placebo Arm
Duration of Stool Output in Excess of 400 mL/Hour5 (2 to 6)8 (3 to 8.5)
Statistical analysis
  • VR-AD-1005 vs Placebo Arm · Wilcoxon (Mann-Whitney) · p = 0.006
SecondaryParticipants With at Least One Adverse Event

Proportion of participants experiencing at least one adverse event (including serious adverse events) following administration of study treatment during the safety evaluation period.

Time frame:
From enrollment until the end of follow-up, up to 28 days
Reported as:
Count of participants · Participants
Participants With at Least One Adverse Event
ParticipantsVR-AD-1005Placebo
Participants With at Least One Adverse Event10

Adverse events

Collected over From enrollment until the end of follow-up, up to 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VR-AD-10051/75 (1.3%)1/75 (1.3%)0/75 (0%)
Placebo0/75 (0%)0/75 (0%)0/75 (0%)
Most frequent serious events
Most frequent serious events
EventVR-AD-1005Placebo
DeathVascular disorders1/75—

Baseline characteristics

This study recruited 150 participants in total, meeting the inclusion criteria, of which 75 participants were double-blindly assigned to the Active Arm and 75 participants were assigned to the Placebo Arm. Following randomization, 5 participants failed stool culture confirmation in the Active group and 3 participants failed in the Placebo group (screen failures), yielding 70 analyzable participants in the Active group and 72 in the placebo group.

Age, Categorical
Age, Categorical(Participants)VR-AD-1005PlaceboTotal
<=18 years000
Between 18 and 65 years7072142
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)VR-AD-1005PlaceboTotal
Female251742
Male4555100
Weight
Weight(kg)VR-AD-1005PlaceboTotal
Mean52.35 ± 8.2152.97 ± 9.9952.66 ± 9.13
Acute watery diarrhea
Acute watery diarrhea(hours)VR-AD-1005PlaceboTotal
Mean15 ± 13.915.57 ± 11.1215.29 ± 12.53
Episodes (diarrhea)
Episodes (diarrhea)(number of episodes)VR-AD-1005PlaceboTotal
Mean26.03 ± 14.5526.61 ± 11.7126.32 ± 13.14
Vomiting
Vomiting(hours)VR-AD-1005PlaceboTotal
Mean10.56 ± 9.4010.16 ± 7.8810.36 ± 8.64
Episodes (vomiting)
Episodes (vomiting)(number of episodes)VR-AD-1005PlaceboTotal
Mean10.88 ± 7.779.85 ± 6.8210.37 ± 7.30
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)VR-AD-1005PlaceboTotal
Count of participants——0
08

Study locations

1 site
  • Icddr,b
    Dhaka, Bangladesh
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06193408
Lead sponsor
Hunazine Biotech S.L.
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Feb 11, 2024
Primary completion
Aug 11, 2024
Completion
Sep 8, 2024
Results posted
Mar 12, 2026
Last update
Jun 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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