A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie

About this trial

The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Disqualifiers

Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.

Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risankizumab

    Drug

    Intravenous (IV)

  • Risankizumab

    Drug

    Subcutaneous (SC) Injections

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Risankizumab Dose AExperimental treatment 1 intervention
Group B: Risankizumab Dose BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Time frame
Up to Approximately 155 Days
2

Maximum Observed Serum Concentration (Cmax) of Risankizumab

Cmax of Risankizumab.

Time frame
Up to Approximately 155 Days
3

Time to Cmax (Tmax) of Risankizumab

Tmax of Risankizumab.

Time frame
Up to Approximately 155 Days
4

Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab

AUCt of Risankizumab.

Time frame
Up to Approximately 155 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

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