Eine Sicherheitsstudie zu intravenös verabreichtem UTTR1147A bei gesunden Proband*innen, Teilnehmenden mit Colitis ulcerosa (CU) und Teilnehmenden mit Morbus Crohn (CD)

A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

  • Autoimmunerkrankung
  • Chronisch-entzündliche Darmerkrankung (CED)
  • Colitis Ulcerosa
  • Gesunde Freiwillige
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Status der Studie:

Abgeschlossen

Diese Studie läuft in
Stadt
  • Berlin
Studien-ID:

NCT02749630 2015-002512-32 GA29469

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02749630,GA29469,2015-002512-32 Studien-ID
      Placebo, UTTR1147A Treatments
      Ulcerative Colitis, Crohn's Disease Condition
      Official Title

      An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease

      Einschlusskriterien

      All Gender
      ≥ 18 Years & ≤ 80 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria

      General inclusion criteria:

      • No history of malignancy
      • Documentation of age-appropriate cancer screening based on local/country-specific guidelines
      • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
      • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

      For HVs Only:

      • Age 18 - 50
      • Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2), inclusive
      • In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs, and clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor

      For Participants with UC or CD:

      • Age 18 - 80
      • Eligible to receive biologic therapy
      • Disease duration of >/= 12 weeks
      • Diagnosis of moderate to severe UC or CD
      Exclusion Criteria

      General exclusion criteria:

      • History of inflammatory skin disorders
      • History of any cancer
      • History of anaphylaxis, hypersensitivity, or drug allergies
      • History of alcoholism or drug addiction
      • Positive tests indicating infection for hepatitis C, hepatitis B, or HIV
      • Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days or 5 half-lives of investigational product, whichever is greater, prior to study drug administration
      • Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration
      • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
      • Family history of sudden unexplained death or long QT syndrome
      • Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
      • Pregnant or lactating, or intending to become pregnant for duration of study

      For HVs Only:

      • Known family history of gastrointestinal (GI) and/or colon cancer
      • Prior exposure to UTTR1147A

      For Participants with UC or CD:

      • Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders
      • History of primary sclerosing cholangitis
      • Active anti-TNF induced psoriasiform or eczematous lesions
      • Moderate to severe anemia
      • Presence of an ileostomy or colostomy
      • Total proctocolectomy
      • Positive screening for latent mycobacterial tuberculosis infection
      • Impaired renal function
      • Impared hepatic function

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