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Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

NCT04183491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-04-22

Study results available
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Summary

This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.

This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

Conditions

  • Healthy Subjects
  • Pharmacokinetics
  • Pharmacodynamics

Interventions

BIOLOGICAL

Interferon beta-1a

Interferon beta-1a 7.5 µg administered IM

BIOLOGICAL

Interferon beta-1a

Interferon beta-1a 15 µg administered IM

BIOLOGICAL

Interferon beta-1a

Interferon beta-1a 30 µg administered IM

BIOLOGICAL

Peginterferon beta-1a

Peginterferon beta-1a 31.25 µg administered SC

BIOLOGICAL

Peginterferon beta-1a

Peginterferon beta-1a 62.5 µg administered SC

BIOLOGICAL

Peginterferon beta-1a

Peginterferon beta-1a 125 µg administered SC

BIOLOGICAL

Placebo

Placebo (administered either IM or SC)

Sponsors & Collaborators

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Carlos Sanabria, MD · Spaulding Clinical Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2021-01-26
Completion
2021-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04183491 on ClinicalTrials.gov