A study to assess the safety and processing by the body of GDC-5780 in healthy participants

Phase 1

Completed

• Conditions: Healthy volunteers; Not Applicable

• Registration Number: ISRCTN15259645
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Study Completion: 2023-12-08
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Age 18 - 65 years at time of signing informed consent form (ICF)
2. Body mass index (BMI) of = 18.5 and < 30 kilograms per metre squared (kg/m^2) at screening
3. Ability to comply with study protocol

Exclusion Criteria

1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of study drug
2. Planned procedure or surgery during the study
3. Positive human immunodeficiency virus (HIV) test at screening
4. Positive hepatitis B surface antigen (HBsAg) test at screening
5. Positive hepatitis C virus (HCV) antibody test at screening
6. Any serious medical condition or abnormality in clinical laboratory tests
7. History of malignancy within 5 years prior to screening
8. Acute illness within 14 days prior to screening
9. Vaccination within 14 days prior to initiation of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence and severity of adverse events (AEs), with severity determined according to the Division of AIDS (DAIDS) toxicity grading scale and a modified Common Terminology Criteria for Adverse Events (CTCAE) grading scale for infusion related reactions, measured using data from electronic Case Report Forms (eCRFs) from initiation of the study up to Day 38<br>2. Incidence and severity of vital sign, laboratory test, and electrocardiogram (ECG) abnormalities measured using data from vital signs recorded (respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature), laboratory test results (serum/plasma/urine samples), and ECG readings (single 12-lead ECG recordings) from initiation of study to 28 days after the last dose (up to Day 38).