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Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants

NCT07646548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-21

No results posted yet for this study

Summary

This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.

The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.

Study details include:

* The study duration will be approximately up to 12 to 15 weeks.
* The treatment will be administered as a single dose on Day 1.
* The number of visits will be 14.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Dupilumab coformulated with berahyaluronidase alfa

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

BIOLOGICAL

Dupilumab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Angel Lamas, MD · Clinical Pharmacology of Miami (CPMI)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT07646548 on ClinicalTrials.gov