A First Time in Human Study in Healthy Volunteers and Patients

Crohn's Disease Clinical Trial

Official title:

A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010787
• Other study ID #: V56501
• 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

• Crohn Disease
• Crohn's Disease

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