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
| Registry | NCT07835243 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 105 (Estimated) |
| Sponsor | Hoffmann-La Roche (Industry) |
| Conditions | Healthy Volunteers |
| Interventions | Pegozafermin (Drug) |
| Dates | start 2026-11-05 (estimated), primary completion 2027-03-02 (estimated), completion 2027-03-02 (estimated), first posted 2026-09-22, last updated 2026-10-19 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A | Experimental | Drug: Pegozafermin | Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen. |
| Group B | Experimental | Drug: Pegozafermin | Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh. |
| Group C | Experimental | Drug: Pegozafermin | Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm. |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
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.