Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

GALE Therapeutics Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: Placebo; Biological: XmAb942

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619990

G942-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 6 patient groups, including a placebo group

Part A: Active drug

Active Comparator group

Description:

Active XmAb942 to be administered to healthy volunteers (SAD). Participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered once via either subcutaneous injection or intravenous infusion. Each dose cohort will have 8 participants receiving the dose as a subcutaneous injection, and 8 participants receiving the dose as an IV infusion. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. After a safety evaluation period of the dose without clinically significant adverse events (AEs) then 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule. A Safety Review Committee (SRC) will review data prior to escalation to the next dose level.

Treatment:

Biological: XmAb942

Part A: Placebo

Placebo Comparator group

Description:

Placebo Comparator to be administered to healthy volunteers (SAD). Participants will be randomized in a 3:1 ratio to active or placebo. Study intervention will be administered once via either subcutaneous injection or intravenous infusion. Each dose cohort will have 8 participants receiving the dose as a subcutaneous injection, and 8 participants receiving the dose as an IV infusion. Randomization to each SAD cohort will be done in a staggered manner; initially 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. After a safety evaluation period of the dose without clinically significant adverse events (AEs) then 6 additional participants will be randomized and dosed (5 active and 1 placebo) at the discretion of the Investigator according to the randomization schedule. A Safety Review Committee (SRC) will review data prior to escalation to the next dose level.

Treatment:

Drug: Placebo

Part B: Active

Active Comparator group

Description:

Active XmAb942 to be administered to healthy volunteers. Participants will be randomized in a 3:1 ratio to active or placebo. Determination of route of administration will be performed by SRC prior to initiation of Part B. Each dose cohort will have 8 participants receiving the dose as a subcutaneous infusion, and 8 participants receiving the dose as an IV infusion. The SRC may review data for determination of the next dose cohort.

Treatment:

Biological: XmAb942

Part B: Placebo

Placebo Comparator group

Description:

Placebo Comparator to be administered to healthy volunteers. Participants will be randomized in a 3:1 ratio to active or placebo. Determination of route of administration will be performed by SRC prior to initiation of Part B. Each dose cohort will have 8 participants receiving the dose as a subcutaneous infusion, and 8 participants receiving the dose as an IV infusion. The SRC may review data for determination of the next dose cohort.

Treatment:

Drug: Placebo

Part C: Active

Active Comparator group

Description:

Active XmAb942 to be administered to participants with Ulcerative Colitis. The SRC will provide recommendations on the doses in Part C based on emerging Part A and/or Part B data.

Treatment:

Biological: XmAb942

Part C: placebo

Placebo Comparator group

Description:

Placebo Comparator to be administered to participants with Ulcerative Colitis. The SRC will provide recommendations on the doses, frequency and route of administration to be assessed in Part C based on emerging Part A and/or Part B data

Treatment:

Drug: Placebo