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A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants

NCT05670704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-08-23

No results posted yet for this study

Summary

This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration.

This study will include 2 parts:

* In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort.
* In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ARGX-119

Patients receiving ARGX-119 IV or SC

OTHER

Placebo

Patients receiving Placebo IV or SC

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-08-08
Completion
2024-08-08

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670704 on ClinicalTrials.gov