- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07835243
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Studera Kontakt Backup
- Namn: Reference Study ID Number: GP46978 https://forpatients.roche.com/ No attachments to email below
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-post: global-roche-genentech-trials@gene.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
Tidsram: 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
Tidsram: 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
Tidsram: From predose on Day 1 up to Day 22
|
From predose on Day 1 up to Day 22
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen
Tidsram: Up to Day 22
|
Up to Day 22
|
|
Frel of Pegozafermin for Upper Arm Versus Abdomen
Tidsram: Up to Day 22
|
Up to Day 22
|
|
Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Up to approximately 50 days
|
Up to approximately 50 days
|
|
Number of Participants With Injection Site Reactions (ISRs)
Tidsram: Up to 24 hours post-dose on Day 1
|
Up to 24 hours post-dose on Day 1
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Trials, Hoffmann-La Roche
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- GP46978
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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