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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

PHASE1PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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
  • 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

  • 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
  • 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-10-10

    Primary completion: 2026-10-01

    Study completion finish: 2027-10-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT06619990

    Intervention or treatment

    BIOLOGICAL: XmAb942

    DRUG: Placebo

    Conditions

    • • Ulcerative Colitis (UC)
    Image related to Ulcerative Colitis (UC)

    • Condition: Ulcerative Colitis (UC)

    • BIOLOGICAL: XmAb942 and other drugs

    • Nedlands, Western Australia, Australia

    • Sponsor: GALE Therapeutics Inc.

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Linear Clinical Research

    Research sites nearby

    Select from list below to view details:

    • Linear Clinical Research

      Nedlands, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Part A: Active drug
    • 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.
    BIOLOGICAL: XmAb942
    • Antibody
    PLACEBO_COMPARATOR: Part A: Placebo
    • 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.
    DRUG: Placebo
    • Placebo
    ACTIVE_COMPARATOR: Part B: Active
    • 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.
    BIOLOGICAL: XmAb942
    • Antibody
    PLACEBO_COMPARATOR: Part B: Placebo
    • 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.
    DRUG: Placebo
    • Placebo
    ACTIVE_COMPARATOR: Part C: Active
    • 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.
    BIOLOGICAL: XmAb942
    • Antibody
    PLACEBO_COMPARATOR: Part C: placebo
    • 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
    DRUG: Placebo
    • Placebo

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A cohort)Not Specified20 weeks
    Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) with repeated doses of XmAb942 in healthy volunteers (Part B cohort)Not Specified28 weeks
    Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) with repeated doses of XmAb942 in participants with UC (Part C)Not Specified12 weeks
    Clinical outcomes of multiple doses of XmAb942 in participants with UC, as determined by the Modified Mayo Score, Rectal Bleeding score, Stool Frequency Score, and Endoscopic subscore (Part C)The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. This is calculated by adding the results from Endoscopic Subscore (ES) which measures GI bleeding, Stool Frequency Subscore (SFS) which measures stool frequency per day, and Rectal Bleeding Score (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.12 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Proportion of participants with histologic-endoscopic remission (Part C).Histologic-endoscopic remission (HER) is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).12 weeks
    Proportion of participants with endoscopic remission (Part C).Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.12 weeks
    Proportion of participants with endoscopic improvement (Part C)Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.12 weeks
    Proportion of participants with histologic-endoscopic improvement (Part C).Histologic-endoscopic improvement is defined as a Geboes score ≤3.1, together with a Mayo Score for ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.12 weeks
    Change from baseline in partial Modified Mayo score (Part C).The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (typical number of stools per day for the participant) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (only passing blood). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.12 weeks
    Proportion of participants with clinical response per Modified Mayo Score (MMS) (Part C).The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. This is calculated by adding the results from Endoscopic Subscore (ES) which measures bleeding GI bleeding, Stool Frequency Subscore (SFS) which measures stool frequency per day, and Rectal Bleeding Score, which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.12 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)Cmax (Maximum concentration of drug in plasma)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)Tmax (Time to maximum concentration of drug in plasma)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)AUC0-last(Area under the plasma drug concentration-time curve to last concentration)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)AUC0-inf(Area under the plasma drug concentration-time curve from 0 to infinity)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)t1/2(Terminal elimination half-life)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (subcutaneous cohort)AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal ruleup to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)Cmax (Maximum concentration of drug in plasma)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)Tmax (Maximum concentration of drug in plasma)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)AUC0-last (Area under the plasma drug concentration-time curve to last concentration)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)AUC0-inf (Area under the plasma drug concentration-time curve from 0 to infinity)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)T1/2 (Terminal elimination half-life)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state)up to 28 weeks
    Plasma pharmacokinetics of XmAb942 in healthy volunteers (IV cohort)AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal ruleup to 28 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)Cmax (Maximum concentration of drug in plasma)up to 12 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)Tmax (Time to maximum concentration of drug in plasma)up to 12 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)AUC0-last (Area under the plasma drug concentration-time curve to last concentration)up to 12 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)AUC0-inf (Area under the plasma drug concentration-time curve from 0 to infinity)up to 12 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)T1/2 (Terminal elimination half-life)up to 12 weeks
    Plasma pharmacokinetics of XmAb942 in participants with Ulcerative Colitis (Part C)CL/F (Apparent) total body clearance, calculated as: Dose / AUCinf or Dose / AUCtau (steady state)up to 12 weeks

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

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