Study of GSK3511294 in Healthy Chinese Participants

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140200
• Other study ID #: 208021
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• GSK3511294
GSK3511294 will be administered.

Locations

Country	Name	City	State
China	GSK Investigational Site	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK3511294		Up to Week 26
Primary	AUC from time 0 (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) of GSK3511294		Up to Week 26
Primary	AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294		Up to Week 4
Primary	AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294		Up to Week 12
Primary	AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294		Up to Week 26
Primary	Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294		Up to Week 26
Primary	Maximum observed plasma concentration (Cmax) of GSK3511294		Up to Week 26
Primary	Time of occurrence of Cmax (tmax) of GSK3511294		Up to Week 26
Primary	Time to last quantifiable concentration (tlast) of GSK3511294		Up to Week 26
Primary	Apparent clearance (CL/F) of GSK3511294		Up to Week 26
Primary	Apparent volume of distribution (Vz/F) of GSK3511294		Up to Week 26
Primary	Terminal elimination rate constant (lambda z) of GSK3511294		Up to Week 26
Primary	Terminal phase half-life (t1/2) of GSK3511294		Up to Week 26
Secondary	Number of participants with adverse events (AEs) and serious adverse events (SAEs)		Up to Week 30
Secondary	Change from Baseline in platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils (10^9 cells per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Red blood cell (RBC) count (10^12 cells per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Hemoglobin (Grams per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in hematocrit (Proportion of RBC in blood)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in mean corpuscular volume (Femtoliters)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in mean Corpuscular Hemoglobin (Picograms)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Sodium, potassium, calcium, Blood urea nitrogen (Millimoles per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) (International units per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in Albumin, Total Protein (Grams per liter)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Absolute values of Complement (C) 3 and C4		Up to Week 26
Secondary	Ratio to Baseline of C3 and C4		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in body temperature (Degrees Celsius)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in pulse rate (Beats per minute)		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Change from Baseline in PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) (Milliseconds [msec])		Baseline (Pre-dose on Day 1) and up to Week 26
Secondary	Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294		Up to Week 26
Secondary	Titers of ADA against GSK3511294		Up to Week 26