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

GS-US-496-5619: A Phase 1 Study in Healthy Volunteers to Evaluate the Single Dose Pharmacokinetics, Safety, and Tolerability of GS-3583.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001051932

Enrollment

Registered

2020-10-15

Start date

2020-10-13

Completion date

2021-06-14

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

GS-US-496-5619 is being developed for use in combination with a range of cancer treatments. This is the first study of GS-3583 in humans. The trial aims to: - Assess how safe and well-tolerated single doses of GS-3583 are. - Measure levels of GS-3583 in the blood over time, following a single dose (pharmacokinetics or PK). - Measure the body's response to a single dose of GS-3583 (pharmacodynamics or PD). Approximately 40 healthy adults will be enrolled into 4 planned dose groups. Every participant will receive a single dose of GS-3583 or matching placebo, given as an infusion into a vein. Blood samples to measure study drug levels and the body's response to the drug will be collected at specific time points during the study, safety will be closely monitored, and any changes in health will be recorded. The results will be used to inform further clinical development of GS-3583.

Interventions

Every participant will receive a single dose of GS-3583 or matching placebo, given as an infusion into a vein. Participants will only be allowed in 1 cohort in the study. Each participant will attend the facility for dosing under supervision. Dose Ranges: - Cohort 1 75 µg GS-3583 or placebo - Cohort 2 Up to 225 µg GS-3583 or placebo - Cohort 3 Up to 675 µg GS-3583 or placebo - Cohort 4 Up to 2000 µg GS-3583 or placebo

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Outcome results