A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
- Summary
- This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
- Short title
- A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
- Official title
- An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-10-23
- First posted
- 2022-11-01
- Registry last updated
- 2026-06-16
- Primary completion date
- 2023-10-23
- Start date
- 2022-12-13
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05602025
- ClinicalTrials.gov ID
- NCT05602025
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Maximum Observed Plasma Concentration (Cmax) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Terminal Elimination Rate Constant (Lambda z) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Terminal Elimination Half-Life (T1/2) Following Administration of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Time of Last Measurable Plasma Concentrations (Tlast) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Percentage of AUC (0-Inf) Due to Extrapolation From the Time of the Last Observed Concentration (Tlast) to Infinity (%AUCex) of Depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. The percentage of AUC (0-inf) obtained by extrapolation (%AUCex) was calculated as: (AUC\[0-inf\] - AUC\[0-t\]) /AUC(0-inf)\*100.
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26
Blood samples were collected and analyzed for the presence of anti- depemokimab antibodies using a validated immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26
Blood samples were collected for determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- Yes
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
- Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
- Women who have the potential to become pregnant must use a form of highly-effective contraception.
- Capable of giving signed informed consent.
- History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/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.
- Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
- Recent prior or concurrent clinical study experience.
- GSK Investigational SiteOrlando, United States
- GSK Investigational SiteLas Vegas, United States
- GSK Investigational SiteAustin, United States
Related records
Drugs (1)
Collaborators (1)
Lead sponsors (1)
Conditions (1)
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