Overview
Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with Ulcerative Colitis.
Description
This study is a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, followed by a cohort of three repeating doses in healthy volunteers. The third part of this study will be a Phase 2, randomized, placebo controlled, double blind evaluation of participants with Ulcerative Colitis with a dose determined from Parts A and B.
This study consists of 3 parts, as follows:
Part A: SAD in healthy participants, will entail administration of XmAb942 or matching placebo.
Part B: Repeat Dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo.
Part C: Participants with UC to receive XmAb942 or placebo with dose determined from Part A and Part B.
Eligibility
Inclusion Criteria:
Parts A and B
- Age 18-55
- Must be in good health with no significant medical history
- Clinical laboratory values within normal range
- BMI 18-35 (inclusive)
- Contraceptive use by men or women consistent with local regulations
- Able and willing to provide written informed consent
Part C
- Age 18-55
- Must be in good health with no significant medical history
- UC diagnosis
- Clinical laboratory values within normal range
- BMI 18-35 (inclusive)
- Contraceptive use by men or women consistent with local regulations
- Able and willing to provide written informed consent
Exclusion Criteria:
Parts A and B
- Any physical or psychological condition that prohibits study completion
- History of suicidal behavior or suicidal ideation
- Heavy use of nicotine containing products
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- Active use of prescription medications within 14 days of Day -1
- Active use of over-the-counter, or herbal medication within 7 days of Screening
- Other investigational products within 30 days
- Blood or plasma donation within 60 days
- Pregnant or breastfeeding
Part C
- Any physical or psychological condition that prohibits study completion
- Diagnosis of Crohn disease, pouchitis, or indeterminate colitis
- Positive screen for Clostridium difficile (C. Difficile)
- History of suicidal behavior or suicidal ideation
- Heavy use of nicotine containing products
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- Other investigational products within 30 days
- Blood or plasma donation within 60 days
- Pregnant or breastfeeding