Last updated: 01/24/2025 11:10:18

Study of GSK3511294 in healthy Chinese participants

GSK study ID
208021
Clinicaltrials.gov ID
NCT05140200
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, single dose study to investigate the pharmacokinetics, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
Trial description: This single dose pharmacokinetic (PK) study aims to
investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK3511294

Timeframe: Up to Week 26

AUC from time 0 (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) of GSK3511294

Timeframe: Up to Week 26

AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294

Timeframe: Up to Week 4

AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294

Timeframe: Up to Week 12

AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294

Timeframe: Up to Week 26

Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294

Timeframe: Up to Week 26

Maximum observed plasma concentration (Cmax) of GSK3511294

Timeframe: Up to Week 26

Time of occurrence of Cmax (tmax) of GSK3511294

Timeframe: Up to Week 26

Time to last quantifiable concentration (tlast) of GSK3511294

Timeframe: Up to Week 26

Apparent clearance (CL/F) of GSK3511294

Timeframe: Up to Week 26

Apparent volume of distribution (Vz/F) of GSK3511294

Timeframe: Up to Week 26

Terminal elimination rate constant (lambda z) of GSK3511294

Timeframe: Up to Week 26

Terminal phase half-life (t1/2) of GSK3511294

Timeframe: Up to Week 26

Secondary outcomes:

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Week 30

Change from Baseline in platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils (10^9 cells per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Red blood cell (RBC) count (10^12 cells per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Hemoglobin (Grams per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in hematocrit (Proportion of RBC in blood)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in mean corpuscular volume (Femtoliters)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in mean Corpuscular Hemoglobin (Picograms)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Sodium, potassium, calcium, Blood urea nitrogen (Millimoles per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) (International units per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in Albumin, Total Protein (Grams per liter)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Absolute values of Complement (C) 3 and C4

Timeframe: Up to Week 26

Ratio to Baseline of C3 and C4

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in body temperature (Degrees Celsius)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in pulse rate (Beats per minute)

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Change from Baseline in PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) (Milliseconds [msec])

Timeframe: Baseline (Pre-dose on Day 1) and up to Week 26

Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294

Timeframe: Up to Week 26

Titers of ADA against GSK3511294

Timeframe: Up to Week 26

Interventions:
  • Biological/vaccine: GSK3511294
    • Enrollment:
    20
    Primary completion date:
    2022-23-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2021 to December 2022
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 Years
    Accepts healthy volunteers
    Yes
    • Participant between 18 to 45 years of age.
    • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
    • Participant is pregnant, breastfeeding, or a woman of childbearing potential
    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant between 18 to 45 years of age.
    • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
    • Body weight greater than or equal to (>=)50.0 kilograms (kg) for males, >=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m^2) (inclusive).
    • Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • Capable of giving signed informed consent.
    Exclusion criteria:
    • Participant is pregnant, breastfeeding, or a woman of childbearing potential
    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
    • Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance
    • Current evidence or recent history of an infective illness
    • A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
    • Clinically significant abnormalities
    • Participants with Coronavirus Disease-2019 (COVID-19)
    • With prior/concurrent clinical study experience.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hangzhou, China, 310006
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2022-23-12
    Actual study completion date
    2022-23-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website