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OpenTrials
Completed

NCT Number: NCT06054425

A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials LLC /ID# 260740, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at the time of screening and upon initial confinement.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
  • Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion criteria

  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
  • Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.

Treatment and study plan

Risankizumab

Drug

Infusion; intravenous

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Up to Day 131

    Cmax will be assessed.

  2. Time to Cmax (Tmax)

    Time frame: Up to Day 131

    Tmax will be assessed.

  3. Apparent Terminal Phase Elimination Rate Constant (β)

    Time frame: Up to Day 131

    Apparent terminal phase elimination rate constant (β) will be assessed.

  4. Terminal Phase Elimination Half-life (t1/2)

    Time frame: Up to Day 131

    Terminal phase elimination half-life (t1/2) will be assessed.

  5. Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)

    Time frame: Up to Day 131

    AUC0-t will be assessed.

  6. AUC from Time 0 to Infinity (AUC0-inf)

    Time frame: Up to Day 131

    AUC0-inf will be assessed.

  7. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 141

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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2023
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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