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OpenTrials
Completed

NCT Number: NCT06067568

Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants

The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.

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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

Altasciences Clinical Los Angeles, Inc /ID# 260986, Cypress, 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

  • Male and female healthy volunteers aged between 18 and 60 years.

-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

  • BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at 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 12-lead electrocardiogram (ECG).

Exclusion criteria

  • Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
  • History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
  • Prior exposure to lutikizumab.

Treatment and study plan

Lutikizumab Dose A

Drug

Injection; subcutaneous (SC)

Lutikizumab Dose B

Drug

Injection; subcutaneous (SC)

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of Lutikizumab

    Time frame: Up to Day 8

    Cmax of lutikizumab will be assessed.

  2. Time to Cmax (Tmax) of Lutikizumab

    Time frame: Up to Day 8

    Tmax of lutikizumab will be assessed.

  3. Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab

    Time frame: Up to Day 8

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

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

    Time frame: Up to Day 8

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

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

    Time frame: Up to Day 8

    AUC0-t of lutikizumab will be assessed.

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

    Time frame: Up to Day 8

    AUC0-inf of lutikizumab will be assessed.

  7. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 71

    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 Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2023
Registry last updated
Mar 15, 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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