Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Start Date
10/10/2024
Completion Date
1/1/2029
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 (UC).
Detailed Description
This study consists of 3 parts, as follows: Part A: Single ascending dose (SAD) in healthy participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942. Part B: Multiple ascending dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942. Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 24 week follow-up period.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
XmAb942
Placebo
Conditions
Locations
Xencor Investigative Site
Scottsdale, Arizona 85255
United States
Xencor Investigative Site
Bradenton, Florida 34209
United States
Xencor Investigative Site
Brandon, Florida 33511
United States
Xencor Investigative Site
Jacksonville, Florida 32258
United States
Xencor Investigative Site
Kissimmee, Florida 34741
United States
Xencor Investigative Site
Margate, Florida 33063
United States
Xencor Investigative Site
Palmetto Bay, Florida 33176
United States
Xencor Investigative Site
Tampa, Florida 33612
United States
Xencor Investigative Site
Tampa, Florida 33613
United States
Xencor Investigative Site
Louisville, Kentucky 40218
United States
Xencor Investigative Site
Oxford, Mississippi 38655
United States
Xencor Investigative Site
Tupelo, Mississippi 38801
United States
Xencor Investigative Site
Albany, New York 12206
United States
Xencor Investigative Site
Rochester, New York 14618
United States
Xencor Investigative Site
Raleigh, North Carolina 27612
United States
Xencor Investigative Site
Beavercreek, Ohio 45440
United States
Xencor Investigative Site
Cordova, Tennessee 38018
United States
Xencor Investigative Site
Cedar Park, Texas 78613
United States
Xencor Investigative Site
Denton, Texas 76201
United States
Xencor Investigative Site
Garland, Texas 75044
United States
Xencor Investigative Site
Georgetown, Texas 78628
United States
Xencor Investigative Site
Houston, Texas 77024
United States
Xencor Investigative Site
Houston, Texas 77090
United States
Xencor Investigative Site
Kingwood, Texas 77339
United States
Xencor Investigative Site
Lubbock, Texas 79424
United States
Xencor Investigative Site
San Antonio, Texas 78229
United States
Xencor Investigative Site
Tyler, Texas 75701
United States
Xencor Investigative Site
Webster, Texas 77598
United States
Xencor Investigative Site
Richmond, Virginia 23229
United States
Xencor Investigative Site
Buenos Aires, C425BGC
Argentina
Xencor Investigative Site
Rosario, S2000
Argentina
Xencor Investigative Site
San Miguel de Tucumán, 4000
Argentina
Xencor Investigative Site
Adelaide, 5000
Australia
Xencor Investigative Site
Joondalup, 6027
Australia
Xencor Investigative Site
Melbourne, 3004
Australia
Xencor Investigative Site
Nedlands, 6009
Australia
Xencor Investigative Site
South Brisbane, 4101
Australia
Xencor Investigative Site
Southport, 4215
Australia
Xencor Investigative Site
Wollongong, 2500
Australia
Xencor Investigative Site
Campinas, 13092-133
Brazil
Xencor Investigative Site
Porto Alegre, 90035-903
Brazil
Xencor Investigative Site
Santo André, 09080-110
Brazil
Xencor Investigative Site
São Paulo, 04543-011
Brazil
Xencor Investigative Site
Votuporanga, 15500-269
Brazil
Xencor Investigative Site
Sofia, 1618
Bulgaria
Xencor Investigative Site
London, N6K 1M5
Canada
Xencor Investigative Site
Montreal, H3H 1EB
Canada
Xencor Investigative Site
Scarborough, M1S4T7
Canada
Xencor Investigative Site
Vancouver, V6Z 2K5
Canada
Xencor Investigative Site
Osijek, 31000
Croatia
Xencor Investigative Site
Rijeka, 51000
Croatia
Xencor Investigative Site
Zagreb, 10000
Croatia
Xencor Investigative Site
Tbilisi, 0112
Georgia
Xencor Investigative Site
Athens, 10676
Greece
Xencor Investigative Site
Heraklion, 71500
Greece
Xencor Investigative Site
Thessaloniki, 54642
Greece
Xencor Investigative Site
Budapest, 1066
Hungary
Xencor Investigative Site
Budapest, 1136
Hungary
Xencor Investigative Site
Budapest, 1139
Hungary
Xencor Investigative Site
Nyíregyháza, H-4405
Hungary
Xencor Investigative Site
Vác, 2600
Hungary
Xencor Investigative Site
Chisinau,
Moldova
Xencor Investigative Site
Bydgoszcz, 85-079
Poland
Xencor Investigative Site
Katowice, 40-748
Poland
Xencor Investigative Site
Krakow, 30-363
Poland
Xencor Investigative Site
Nowy Targ, 34-400
Poland
Xencor Investigative Site
Sopot, 81-756
Poland
Xencor Investigative Site
Staszów, 28-200
Poland
Xencor Investigative Site
Szczecin, 71-685
Poland
Xencor Investigative Site
Warsaw, 00-189
Poland
Xencor Investigative Site
Warsaw, 004-501
Poland
Xencor Investigative Site
Warsaw, 03-580
Poland
Xencor Investigative Site
Wroclaw, 52-416
Poland
Xencor Investigative Site
Wroclaw, 53-611
Poland
Xencor Investigative Site
Loures, 2674-514
Portugal
Xencor Investigative Site
Bucharest, District 1 01-1658
Romania
Xencor Investigative Site
Cluj-Napoca, 400006
Romania
Xencor Investigative Site
Ploieşti, 100032
Romania
Xencor Investigative Site
Timișoara, 300002
Romania
Xencor Investigative Site
Ivano-Frankivsk, 76008
Ukraine
Xencor Investigative Site
Kyiv, 01135
Ukraine
Xencor Investigative Site
Kyiv, 02091
Ukraine
Xencor Investigative Site
Lutsk, 43005
Ukraine
Xencor Investigative Site
Lviv, 79000
Ukraine
Xencor Investigative Site
Lviv, 79010
Ukraine
Xencor Investigative Site
Lviv, 79059
Ukraine
Xencor Investigative Site
Uzhhorod, 88000
Ukraine
Xencor Investigative Site
Vinnytsia, 21009
Ukraine
Xencor Investigative Site
Vinnytsia, 21028
Ukraine
Xencor Investigative Site
Zhytomyr, 10001
Ukraine