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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo PH20 SC; Other: placebo + rHuPH20; Biological: ARGX-117 PH20 SC; Biological: ARGX-117; Biological: ARGX-117 + rHuPH20; Other: Placebo

• Registration Number: NCT04532125
• Lead Sponsor: argenx

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo PH20 SC	Placebo PH20 SC	Subjects receiving placebo PH20 SC
Placebo + rHuPH20	placebo + rHuPH20	Subjects receiving placebo + rHuPH20
ARGX-117 PH20 SC	ARGX-117 PH20 SC	Subjects receiving ARGX-117 PH20 SC
ARGX-117 IV	ARGX-117	Subjects receiving ARGX-117 IV
ARGX-117 + rHuPH20	ARGX-117 + rHuPH20	Subjects receiving ARGX-117 + rHuPH20
Placebo IV	Placebo	Subjects receiving placebo IV

Primary Outcome Measures

Name	Time	Method
Number of (S)AE	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)

Secondary Outcome Measures

Name	Time	Method
Level of anti-drug antibodies	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Immunogenicity against ARGX-117
Total C2 concentration	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Functional complement activity
Area Under The Curve (AUC)	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)
Maximum serum concentrations (Cmax)	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Maximum observed serum concentration
Time to reach maximum serum concentrations (Tmax)	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Time calculated to reach Cmax
Free C2 concentration	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Functional complement activity
CH50 titers	Up to 37 weeks (arm 1) and up to 42 weeks (arm 2)	Functional complement activity

Trial Locations

Locations (1)

Investigator Site 1; 🇳🇱 Groningen, Netherlands