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A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
A Phase 1, Open-Label, Randomized, Single-Dose Study to Evaluate the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Studie Contact Back-up
- Naam: Reference Study ID Number: GP46978 https://forpatients.roche.com/ No attachments to email below
- Telefoonnummer: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Participants with a body mass index (BMI) within the range of 18.5-35.0 kilogram per square meter (kg/m²)
- Participants in good health, as determined by medical history, physical examination findings, vital signs, electrocardiogram (ECG), and clinical laboratory tests at screening and prior to dosing
- Participants with willingness and ability to comply with all study requirements
Exclusion Criteria:
- Participants with a history of pancreatitis or gallbladder/biliary disorders (including cholelithiasis or cholecystitis), clinically significant menstrual abnormalities per investigator judgment, or hypertension
- Participants with known hypersensitivity to pegozafermin or its excipients or history of severe allergic or hypersensitivity reactions that may place the participant at risk
- Participants with any abnormality of the skin such as tattoo(s) or scarring or SC tissue at or near potential injection sites that may interfere with administration or assessment of the injection
- Participants with any history of malignancy
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
- Participants with a positive result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies or p24 antigen at screening
- Participants with significant alcohol consumption, defined as > 14 units/week for females or > 21 units/week for males
- Participants with a history of recent (i.e., 6 months) bone trauma, fracture, or surgery or other clinically significant bone-related conditions
- Participants with poor peripheral venous access
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A
Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen. |
Pergozafermin will be administered as specified in the protocol. |
|
Experimenteel: Group B
Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh. |
Pergozafermin will be administered as specified in the protocol. |
|
Experimenteel: Group C
Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm. |
Pergozafermin will be administered as specified in the protocol. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUClast) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen
Tijdsspanne: Up to Day 22
|
Up to Day 22
|
|
Frel of Pegozafermin for Upper Arm Versus Abdomen
Tijdsspanne: Up to Day 22
|
Up to Day 22
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Terminal Elimination Half-Life (t1/2) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Apparent Systemic Clearance (CL/F) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Apparent Volume of Distribution (Vz/F) of Pegozafermin
Tijdsspanne: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Tijdsspanne: Up to approximately 50 days
|
Up to approximately 50 days
|
|
Number of Participants With Injection Site Reactions (ISRs)
Tijdsspanne: Up to 24 hours post-dose on Day 1
|
Up to 24 hours post-dose on Day 1
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Clinical Trials, Hoffmann-La Roche
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- GP46978
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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