Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Launched by GALE THERAPEUTICS INC. · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called XmAb942 to see how safe it is and how the body processes it in healthy volunteers. The trial has three parts, with the first two parts involving healthy individuals aged 18 to 55 who are in good health and meet specific criteria. In the third part, the study will include participants who have been diagnosed with Ulcerative Colitis (UC), a condition that causes inflammation in the digestive tract.

To be eligible, participants need to be between 18 and 55 years old, have a normal medical history, and have a body mass index (BMI) between 18 and 35. They should also be willing to agree to certain health and safety guidelines, like using contraception if applicable. Participants can expect to undergo various assessments to ensure their safety throughout the study. It's important to know that those with certain health conditions or who have recently used specific medications may not be able to participate. Overall, this trial aims to gather important information that could lead to new treatment options for people with Ulcerative Colitis.

Gender

ALL

Eligibility criteria

• 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