A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects
NCT03334084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-08-31
Summary
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male Subjects
Conditions
- Bioavailability Study
Interventions
- DRUG
-
ARGX-113
intravenous or subcutaneous administration
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Thierry Cousin, MD · argenx
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-10-11
- Primary Completion
- 2018-09-19
- Completion
- 2018-09-19
Countries
- Netherlands
Study Locations
More Related Trials
-
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
NCT01284036 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
NCT04689035 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of ELX-02 in Healthy Adult Subjects
NCT03309605 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants
NCT06189508 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants
NCT03007693 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
NCT01348165 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39393406 in Healthy Participants
NCT02023255 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
NCT01883544 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants
NCT03550950 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Men Tolerate Different Doses of BI 3006337
NCT05076422 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers
NCT01958060 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
NCT03397329 ·Status: COMPLETED ·Phase: PHASE1
-
SAD and MAD Study With IV and SC Doses of ARGX-117
NCT04532125 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of ELX-02 in Healthy Adults
NCT03292302 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Single Ascending Dose Study With ATX101
NCT07107802 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers
NCT02063594 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Single Dose RO6811135 in Healthy Volunteers
NCT01676584 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects
NCT06995001 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
NCT01086813 ·Status: WITHDRAWN ·Phase: PHASE1
-
Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients
NCT05691361 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers
NCT02244203 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide
NCT01366365 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers
NCT04268784 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348
NCT03703505 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101
NCT05238493 ·Status: COMPLETED ·Phase: PHASE1