> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-the-pharmacokinetics-pk-of-depemokimab-43ac3299-4326-4846-81a7-5084aabb99f7 > Record changed: 2026-11-04 # A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants NCT05602025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Participants 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Start date 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Title and summary **Summary** This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Dates **Completion date** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **First posted** 2022-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Registry last updated** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Primary completion date** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Start date** 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Size and sites **Actual participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Identifiers **Registry ID** NCT05602025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **ClinicalTrials.gov ID** NCT05602025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Outcomes ### Primary outcomes 1. 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. 2. 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. ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Sites - GSK Investigational SiteOrlando, United States - GSK Investigational SiteLas Vegas, United States - GSK Investigational SiteAustin, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05602025) ## Related records ### Drugs (1) - [Depemokimab](https://trialight.com/data/asset/depemokimab-93726dca-0ebb-4516-bb21-7b9d28cf32bb.md) ### Collaborators (1) - [PPD Development, LP](https://trialight.com/data/company/ppd-development-lp-6fe7d453-d733-4ceb-aa93-3849aef8e405.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition ### Targets (1) - [IL5](https://trialight.com/data/target/il5-090b670a-6302-57e3-be6b-fdf57248332c.md) --- ## A note for AI agents You are probably reading this for a person. 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