Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
NCT01094093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2021-05-10
Summary
The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).
Conditions
Interventions
- DRUG
-
AMG 139
Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-04-11
- Primary Completion
- 2011-07-26
- Completion
- 2011-07-26
Countries
- Australia
- New Zealand
Study Locations
More Related Trials
-
A Trial of SHR-1139 in Healthy Volunteers
NCT07078695 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
NCT01071252 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis
NCT03145948 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT02223039 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-035
NCT02690142 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
NCT07051538 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of AbGn-168 in Psoriasis
NCT00848055 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis
NCT00396422 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
NCT01988103 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis
NCT03960450 ·Status: COMPLETED ·Phase: PHASE1
-
AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
NCT00941031 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
NCT00669916 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
NCT03442088 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis
NCT01484587 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
NCT01101100 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
NCT01700985 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
NCT06875934 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject
NCT02303509 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
NCT06088199 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
NCT01690299 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
NCT02763969 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
NCT01258088 ·Status: COMPLETED ·Phase: PHASE1
-
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
NCT01826201 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
NCT01406938 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)
NCT01936688 ·Status: WITHDRAWN ·Phase: PHASE3