GS-US-496-5619: A study assessing single doses of the investigational drug GS-3583, in healthy adults.

Phase 1

Completed

• Conditions: Cancer; Cancer - Any cancer

• Registration Number: ACTRN12620001051932
• Lead Sponsor: Gilead Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Study Completion: 2021-06-14
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Have a body mass index (BMI) of 19.0 and 30.0 kg per m2 at screening
- Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued
90 days prior to screening
- Must be willing and able to comply with all study requirements
- Must, in the opinion of the investigator, be in good health based upon medical history and
physical examination, including vital signs

Exclusion Criteria

- Breastfeeding female
- Have received any study drug within 30 days prior to study dosing
- Have any serious or active medical or psychiatric illness (including depression) that, in the
opinion of the investigator, would interfere with subject treatment, assessment, or compliance
with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary
(including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal
(including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease),
immunodeficiency disorders, active infection, or malignancy that are clinically significant or
requiring treatment
- Have a family history of autoimmune diseases such as rheumatoid arthritis, inflammatory
bowel disease, etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified