Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
NCT04920370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2022-02-11
Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Conditions
- Healthy
Interventions
- DRUG
-
ALXN1720 SC
ALXN1720 will be administered via SC route.
- DRUG
-
ALXN1720 IV
ALXN1720 will be administered via IV route.
- DRUG
-
rHuPH20
rHuPH20 will be administered via SC route.
- DRUG
-
Placebo SC
Placebo will be administered via SC route.
- DRUG
-
Placebo IV
Placebo will be administered via IV route.
Sponsors & Collaborators
-
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-04
- Primary Completion
- 2021-11-16
- Completion
- 2021-11-16
Countries
- United Kingdom
Study Locations
More Related Trials
-
A Safety and Tolerability Study of FCN-207 in Healthy Volunteers
NCT04622124 ·Status: COMPLETED ·Phase: PHASE1
-
RDEA3170 PK/PD Study
NCT02608710 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
NCT02078219 ·Status: COMPLETED ·Phase: PHASE2
-
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
NCT04511702 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
NCT04638543 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
NCT01416402 ·Status: COMPLETED ·Phase: PHASE2
-
RDEA3170 Monotherapy in Subjects With Gout
NCT01927198 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
NCT07280156 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
NCT04060173 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
NCT04987294 ·Status: TERMINATED ·Phase: PHASE2
-
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
NCT04956432 ·Status: COMPLETED ·Phase: PHASE3
-
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
NCT05168683 ·Status: COMPLETED ·Phase: PHASE1
-
RDEA3170 and Febuxostat Drug Interaction Study
NCT01883167 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout
NCT01129648 ·Status: COMPLETED ·Phase: PHASE2
-
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
NCT01508702 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
NCT03906006 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Hyperuricaemia on Chronic Renal Disease
NCT03425708 ·Status: UNKNOWN ·Phase: PHASE4
-
Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension?
NCT02237339 ·Status: COMPLETED ·Phase: PHASE4
-
Single and Multiple Dose Study in Japanese Subjects
NCT01872832 ·Status: COMPLETED ·Phase: PHASE1
-
Multiple Dose Study of SHR4640 in Healthy Subjects
NCT02890966 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
NCT02498652 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
NCT03185793 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
NCT01336686 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
NCT05513976 ·Status: UNKNOWN ·Phase: PHASE2
-
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
NCT04236219 ·Status: COMPLETED ·Phase: PHASE1