A First Time in Human Study in Healthy Volunteers and Patients

VHsquared

Status and phase: Completed; Phase 1

Conditions: Crohn's Disease

Treatments: Drug: V565; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010787

V56501

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

47 participants in 5 patient groups, including a placebo group

Part 1

Experimental group

Description:

Single ascending dose of oral V565

Treatment:

Drug: V565

Drug: V565

Drug: V565

Drug: V565

Part 2 - V565

Experimental group

Description:

Single dose level of oral V565 TID for 14 days

Treatment:

Drug: V565

Drug: V565

Drug: V565

Drug: V565

Part 1 and 2 - placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part 3

Experimental group

Description:

Single dose of V565 in patient volunteers

Treatment:

Drug: V565

Drug: V565

Drug: V565

Drug: V565

Part 4

Experimental group

Description:

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

Treatment:

Drug: V565

Drug: V565

Drug: V565

Drug: V565