Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001051932
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
15/10/2020
Date last updated
9/11/2021
Date data sharing statement initially provided
15/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
GS-US-496-5619: A study assessing single doses of the investigational drug GS-
3583, in healthy adults.
Scientific title
GS-US-496-5619: A Phase 1 Study in Healthy Volunteers to Evaluate the Single Dose
Pharmacokinetics, Safety, and Tolerability of GS-3583.
Secondary ID [1] 302077 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 318683 0
Condition category
Condition code
Cancer 316694 316694 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 318374 0
Treatment: Drugs
Comparator / control treatment
Placebo is a lyophilized powder for reconstitution that is formulated with histidine, sucrose, and polysorbate 80 for stabilization. Each vial is manufactured to contain placebo lyophilized drug product to be reconstituted with SWFI. The quantity in each vial ensures a minimum total volume of 5.0 mL can be withdrawn after reconstitution per instructions. The solution will have a pH of 5.9 after reconstitution.
Control group
Placebo

Outcomes
Primary outcome [1] 324825 0
Assess how safe and well-tolerated single doses of GS-3583 via physical exams and Adverse Event tracking of participants via daily questioning by the clinical staff
Timepoint [1] 324825 0
This data will be collected on Days 1-15, 21, 28, 42, 86, 84
Primary outcome [2] 325151 0
Measure levels of GS-3583 in the blood over time (AUCinf, AUClast, %AUCexp, CL, t1/2, Vz, Cmax), following a single dose (pharmacokinetics or PK).
Timepoint [2] 325151 0
On Days 1, 2, 3, 5, 6, 8, 11, 15, 21, 28, 42, 56, 84
Secondary outcome [1] 385865 0
Changes in Pharmacodynamics markers of GS-3583 via blood draw to isolate PBMC and Plasma
Timepoint [1] 385865 0
Days 1, 3, 5, 8, 11, 15, 21, 28, 42, 56, 84

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
14/06/2021
Date of last data collection
Anticipated
15/02/2021
Actual
14/06/2021
Sample size
Target
40
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 22863 0
New Zealand
State/province [1] 22863 0
Auckland

Funding & Sponsors
Funding source category [1] 306495 0
Commercial sector/Industry
Name [1] 306495 0
Gilead Sciences
Country [1] 306495 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
L6 417 St Kilda Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 307022 0
None
Name [1] 307022 0
NA
Address [1] 307022 0
NA
Country [1] 307022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306700 0
Northern B Human and Disability Ethics Committee (HDEC)
Ethics committee address [1] 306700 0
Ethics committee country [1] 306700 0
New Zealand
Date submitted for ethics approval [1] 306700 0
19/08/2020
Approval date [1] 306700 0
23/09/2020
Ethics approval number [1] 306700 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104718 0
Dr Christian Schwabe
Address 104718 0
Auckland Clinical Studies Ltd
PO Box 8963
Auckland
1150
Country 104718 0
New Zealand
Phone 104718 0
+64 9 373 3474
Fax 104718 0
Email 104718 0
[email protected]
Contact person for public queries
Name 104719 0
Christian Schwabe
Address 104719 0
Auckland Clinical Studies Ltd
PO Box 8963
Auckland
1150
Country 104719 0
New Zealand
Phone 104719 0
+64 9 373 3474
Fax 104719 0
Email 104719 0
[email protected]
Contact person for scientific queries
Name 104720 0
Christian Schwabe
Address 104720 0
Auckland Clinical Studies Ltd
PO Box 8963
Auckland
1150
Country 104720 0
New Zealand
Phone 104720 0
+64 9 373 3474
Fax 104720 0
Email 104720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is for supporting regulatory submission only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.