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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03010787
Other study ID # V56501
Secondary ID
Status Completed
Phase Phase 1
First received December 12, 2016
Last updated January 4, 2017
Start date September 2015
Est. completion date March 2016

Study information

Verified date January 2017
Source VHsquared Ltd.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Parts 1 and 2

1. Adult male subjects aged 18 to 45 years inclusive.

2. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.

3. Body weight between 50.0 and 100.0 kg inclusive.

4. Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests

- Part 3

1. Adult male or female subjects aged 18 to 65 years.

2. Ileostomy for a minimum of 18 months for a non malignant disease indication.

3. A BMI between 18.0 and 32.0 kg/m2 inclusive.

4. Body weight between 50.0 and 100.0 kg inclusive.

5. Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests

- Part 4

1. Adult male or female subjects aged 18 to 65 years.

2. A confirmed diagnosis of Crohn's disease for a minimum of 6 months.

3. A BMI between 15.0 and 32.0 kg/m2 inclusive.

4. Subjects who have no other significant co-morbidity (other than those associated with Crohn's disease).

5. Subjects whose medical history, physical examination, clinical laboratory test results and 12-lead ECG have no clinically relevant abnormalities (other than those associated with Crohn's disease).

Exclusion Criteria:

- Parts 1 and 2

1. A clinically significant abnormal medical history or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.

2. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.

3. A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.

4. A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.

5. Previous surgery to the GI tract with the exception of appendectomy.

6. A history of malignancy.

7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.

- Part 3

1. A history of Crohn's disease.

2. A clinically significant abnormal medical history (other than the condition leading to ileostomy) or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.

3. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.

4. A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.

5. A known history of heart disease.

6. Any clinical evidence of active inflammatory bowel disease.

7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.

- Part 4

1. Subjects with severe Crohn's disease such as: those requiring surgery; those with a current abscess; those with a non inflammatory stricture; those with a history of obstruction.

2. Having ever received anti-TNF-a therapy or other biologics.

3. Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Drug:
V565
single ascending dose of V565
V565
Multiple dose
Placebo
Single and multiple dose
V565
Open-label single dose
V565
Open-label single ascending dose

Locations

Country Name City State
United Kingdom Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd London

Sponsors (1)

Lead Sponsor Collaborator
VHsquared Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs Up to 14 days Yes
Primary Measurement of the concentrations of V565 in ileal fluid following a single dose 24 hours No
Secondary Evaluation of pharmacokinetic parameter of V565: Cmax 72 hours No
Secondary Evaluation of pharmacokinetic parameter of V565: AUC 72 hours No
Secondary Evaluation of pharmacokinetic parameter of V565: tmax 72 hours No
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