First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRegeneron Pharmaceuticals
About this trial
This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.
The study is looking at:
* What side effects REGN20423 might cause * How much REGN20423 is in the blood at different times * How well REGN20423 works in adults with atopic dermatitis * Whether the body makes antibodies against REGN20423 * How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others * What the best dose of REGN20423 is
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit
Has a history of AD for at least 6 months at screening
Has EASI score ≥5 at both the screening and baseline visits
Disqualifiers
Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit
Hypersensitivity to the study treatment or any of its excipients
History of clinical parasite infection, except treated trichomoniasis
Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
Trial design
Design model
Sequential
Treatments tested in this trial
REGN20423
DrugAdministered per the protocol
Placebo
Other interventionAdministered per the protocol
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Part AExperimental treatment 2 interventions
Group B: Part BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to 69 weeks2
Severity of TEAEs
Time frame
Up to 69 weeksSecondary outcomes
1
Concentrations of REGN20423 in serum
Time frame
Up to 57 weeks2
Absolute values from baseline of total Interleukin 13 (IL-13)
Time frame
Up to 52 weeks3
Absolute values from baseline of total Immunoglobulin E (IgE)
Time frame
Up to 52 weeks4
Absolute values from baseline of total eosinophil counts in blood
Time frame
Up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov