A First Time in Human Study in Healthy Volunteers and Patients

NCT ID: NCT03010787

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

Brief Summary

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

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Part 1

Single ascending dose of oral V565

Group Type: EXPERIMENTAL

V565

Intervention Type: DRUG

single ascending dose of V565

Part 2 - V565

Single dose level of oral V565 TID for 14 days

Group Type: EXPERIMENTAL

V565

Intervention Type: DRUG

Multiple dose

Part 1 and 2 - placebo

Oral placebo single dose (Part 1) or TID for 14 days (Part 2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single and multiple dose

Part 3

Single dose of V565 in patient volunteers

Group Type: EXPERIMENTAL

V565

Intervention Type: DRUG

Open-label single dose

Part 4

Single ascending dose of V565 in patients with Crohn's Disease

Group Type: EXPERIMENTAL

V565

Intervention Type: DRUG

Open-label single ascending dose

Interventions

V565

single ascending dose of V565

Intervention Type: DRUG

V565

Multiple dose

Intervention Type: DRUG

Placebo

Single and multiple dose

Intervention Type: DRUG

V565

Open-label single dose

Intervention Type: DRUG

V565

Open-label single ascending dose

Intervention Type: DRUG

Eligibility 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-α therapy or other biologics.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VHsquared Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suhail Nurbhai, MBChB

Role: STUDY_DIRECTOR

VHsquared Ltd.

Locations

Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

V56501

Identifier Type: -

Identifier Source: org_study_id