MedTrace Logo

Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants

NCT04491838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-23

No results posted yet for this study

Summary

The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Process B)

The secondary objectives of the study are:

* Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes
* Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes

Conditions

  • Healthy Volunteer

Interventions

DRUG

Pozelimab

Single subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-03-05
Completion
2021-03-05
FDA Drug
Yes

Countries

  • Belgium

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 NCT04491838 on ClinicalTrials.gov