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SAD and MAD Study With IV and SC Doses of ARGX-117

NCT04532125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-09-21

No results posted yet for this study

Summary

This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. Up to 112 healthy, adult male and female subjects of non-childbearing potential will be enrolled in this trial.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ARGX-117

Subjects treated with ARGX-117

OTHER

Placebo

Subjects treated with placebo

BIOLOGICAL

ARGX-117 + rHuPH20

Subjects treated with ARGX-117 + rHuPH20

OTHER

placebo + rHuPH20

Subjects treated with placebo + rHuPH20

BIOLOGICAL

ARGX-117 PH20 SC

Subjects treated with ARGX-117 PH20 SC

OTHER

Placebo PH20 SC

Subjects treated with placebo PH20 SC

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2022-08-26
Completion
2022-08-26

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 NCT04532125 on ClinicalTrials.gov