Clinical trial NCT05140200: Study of GSK3511294 in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Single dose study
Immunogenicity
GSK3511294
Chinese healthy participants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: 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
measure: 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
measure: AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294
timeFrame: Up to Week 4
measure: AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294
timeFrame: Up to Week 12
measure: AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294
timeFrame: Up to Week 26
measure: Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294
timeFrame: Up to Week 26
measure: Maximum observed plasma concentration (Cmax) of GSK3511294
timeFrame: Up to Week 26
measure: Time of occurrence of Cmax (tmax) of GSK3511294
timeFrame: Up to Week 26
measure: Time to last quantifiable concentration (tlast) of GSK3511294
timeFrame: Up to Week 26
measure: Apparent clearance (CL/F) of GSK3511294
timeFrame: Up to Week 26
measure: Apparent volume of distribution (Vz/F) of GSK3511294
timeFrame: Up to Week 26
measure: Terminal elimination rate constant (lambda z) of GSK3511294
timeFrame: Up to Week 26
measure: Terminal phase half-life (t1/2) of GSK3511294
timeFrame: Up to Week 26
Secondary outcomes:
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Week 30
measure: 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
measure: 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
measure: Change from Baseline in Hemoglobin (Grams per liter)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in hematocrit (Proportion of RBC in blood)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in mean corpuscular volume (Femtoliters)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in mean Corpuscular Hemoglobin (Picograms)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: 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
measure: Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: 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
measure: Change from Baseline in Albumin, Total Protein (Grams per liter)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Absolute values of Complement (C) 3 and C4
timeFrame: Up to Week 26
measure: Ratio to Baseline of C3 and C4
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in body temperature (Degrees Celsius)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: Change from Baseline in pulse rate (Beats per minute)
timeFrame: Baseline (Pre-dose on Day 1) and up to Week 26
measure: 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
measure: Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294
timeFrame: Up to Week 26
measure: Titers of ADA against GSK3511294
timeFrame: Up to Week 26
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: