Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
NCT02881853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2017-07-11
Summary
This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in healthy subjects and in subjects with atopic disease.
Conditions
- Healthy Volunteers
- Atopic Disease
Interventions
- DRUG
-
XmAb7195
- DRUG
Sponsors & Collaborators
-
ICON Early Phase Services, LLC
collaborator UNKNOWN -
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Emanuel P DeNoia, MD · ICON Early Phase Services, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-08-17
- Primary Completion
- 2017-02-24
- Completion
- 2017-02-24
Countries
- United States
Study Locations
More Related Trials
-
A Single-Dose Study of LY3471851 in Healthy Participants
NCT04998487 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
NCT06438263 ·Status: COMPLETED ·Phase: PHASE1
-
Tofacitinib Citrate Topical Gel 3.2% FDA BA Bridging Study
NCT04468425 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
NCT06342713 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
NCT06959225 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06411379 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
NCT06243198 ·Status: COMPLETED ·Phase: PHASE1
-
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
NCT06082323 ·Status: RECRUITING ·Phase: PHASE1
-
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
NCT02380287 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants
NCT03707717 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
NCT02780674 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
NCT07049575 ·Status: RECRUITING ·Phase: PHASE1
-
Subcutaneous Pharmacokinetics of Belatacept
NCT00569803 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
NCT07262983 ·Status: RECRUITING ·Phase: PHASE1
-
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
NCT05233410 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
NCT06268860 ·Status: COMPLETED ·Phase: PHASE1
-
Rituximab in the Treatment of Patients With Bullous Pemphigoid
NCT00286325 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
NCT04242498 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
NCT02466243 ·Status: TERMINATED ·Phase: PHASE2
-
Topical Ruxolitinib Evaluation in Chronic Hand Eczema
NCT05906628 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3549492 in Healthy Participants
NCT04758234 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
NCT05292131 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
NCT05322473 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
NCT05635838 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
NCT06921850 ·Status: RECRUITING ·Phase: PHASE3