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Completed

NCT Number: NCT04147338

A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services, Mannheim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
  • Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
  • Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention

Exclusion criteria

  • History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurologic or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence
  • Has a current chronic infection, prior history of recurrent infection, or an active infection
  • Has previously received guselkumab
  • Has a positive urine drug and alcohol screen during screening or at admission (Day -1)

Treatment and study plan

Guselkumab

Drug

Guselkumab will be administered subcutaneously.

Other names: CNTO 1959

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Up to Day 85

    Cmax is the maximum observed serum concentration.

  2. Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])

    Time frame: Up to Day 85

    AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.

Secondary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 113 days

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state.

  2. Number of Participants with Clinically Significant Vital Signs Abnormalities

    Time frame: Up to 113 days

    Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported.

  3. Number of Participants with Clinically Significant Physical Examination Abnormalities

    Time frame: Up to 113 days

    Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported.

  4. Number of Participants with Clinically Significant Laboratory Abnormalities

    Time frame: Up to 113 days

    Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.

  5. Number of Participants with Anti-Guselkumab Antibodies

    Time frame: Up to Day 85

    Number of participants with anti-drug antibodies to guselkumab will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2019
Registry last updated
Feb 3, 2025

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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