A First Time in Human Study in Healthy Volunteers and Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03010787
• Date of registration: 12/12/2016
• Prospective Registration: No
• Primary sponsor: VHsquared Ltd.
• Public title: A First Time in Human Study in Healthy Volunteers and Patients
• Scientific 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
• Date of first enrolment: September 2015
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03010787
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Suhail Nurbhai, MBChB
• Affiliation: VHsquared Ltd.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: V565

Drug: Placebo

Primary Outcome(s)

Measurement of the concentrations of V565 in ileal fluid following a single dose [Time Frame: 24 hours]

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECGs or vital signs [Time Frame: Up to 14 days]

Secondary Outcome(s)

Evaluation of pharmacokinetic parameter of V565: AUC [Time Frame: 72 hours]

Evaluation of pharmacokinetic parameter of V565: Cmax [Time Frame: 72 hours]

Evaluation of pharmacokinetic parameter of V565: tmax [Time Frame: 72 hours]

Secondary ID(s)

V56501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors