Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000453381
Ethics application status
Approved
Date submitted
24/03/2017
Date registered
28/03/2017
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double-blind, placebo-controlled study of single ascending doses of PTG-300 in normal healthy male subjects
Scientific title
A randomized, double-blind, placebo-controlled study of single ascending doses of PTG-300 in normal healthy male subjects
Secondary ID [1] 291542 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thalassemia (beta) 302579 0
Condition category
Condition code
Human Genetics and Inherited Disorders 302104 302104 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: PTG300 1mg subcutaneous injection of 0.9mL, once
Cohort 2: PTG300 3mg subcutaneous injection of 0.9mL, once
Cohort 3: PTG300 10mg subcutaneous injection of 0.9mL, once
Cohort 4 PTG300 20mg subcutaneous injection of 0.9mL, once
Cohort 5: PTG300 40mg subcutaneous injection of 0.9mL, once
Cohort 6: PTG300 80mg subcutaneous injection of 0.9mL, once
Cohort 7: 2 x PTG300 40mg subcutaneous injections of 0.9mL, one week apart
Intervention code [1] 297571 0
Treatment: Drugs
Comparator / control treatment
Placebo: 0.9% NaCl solution administered as subcutaneous injection of 0.9mL, once or twice
Control group
Placebo

Outcomes
Primary outcome [1] 301545 0
Safety and tolerability will be assessed using vital signs, clinical safety labs, ECGs, physical exams and adverse events.
Timepoint [1] 301545 0
C1 - C6: Daily in-patient monitoring for 7 days following first dose plus follow up visit on Day 14
C7: Daily in-patient monitoring for 7 days following first dose and 12 days following second dose
Secondary outcome [1] 332988 0
Plasma and urine pharmacokinetics of PTG300, including AUC, Tmax, Cmax, T1/2
Timepoint [1] 332988 0
C1 - C6: Plasma: At 1, 2, 4, 8, 24, 48, 72, 96, 120 and 168 hours post dose Urine: pooled over 24 hours post-dose

C7: Plasma: At 2, 8, 24, 48, 72, 96, 120 and 144 hours post first dose and At 2, 8, 24, 48, 72, 96, 120, 144, 168, 192 hours post second dose. Urine: pooled over 24 hours post each dose
Secondary outcome [2] 332989 0
Effects of PTG300 on measures of iron in plasma (serum Fe, ferritin, transferrin)
Timepoint [2] 332989 0
C1 - C6: At 1, 4, 8, 24, 48, 72, 96, 120 and 168 hours, and 14 days, post dose

C7: At 2 and 8 hours post each dose, and every 24 hours from Day 1 to Day 21

Eligibility
Key inclusion criteria
Healthy male volunteers aged 18-60.
Good general health,
Body weight at least 50 kg and Body Mass Index between 18 and 30 kg/m2.
No clinically significant laboratory values
Non-smokers
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Iron supplementation or history of iron deficiency anaemia
History of significant abnormalities or diseases
Clinical significant laboratory, vital sign or ECG abnormalities
Mentally or legally incapacitated
History of substance abuse
Inability to comply with the requirements of the study protocol

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
Review of data by cohort before decision to progress to the next cohort
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2017
Actual
22/05/2017
Date of last participant enrolment
Anticipated
Actual
13/09/2017
Date of last data collection
Anticipated
Actual
18/10/2017
Sample size
Target
62
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295989 0
Commercial sector/Industry
Name [1] 295989 0
Protagonist Therapeutics, Inc.
Country [1] 295989 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Protagonist Therapeutics, Inc.
Address
7707 Gateway Blvd., Suite 140
Newark, CA 94560
Country
United States of America
Secondary sponsor category [1] 294876 0
Commercial sector/Industry
Name [1] 294876 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 294876 0
88 Jephson Street
Toowong
QLD 4066
Country [1] 294876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297251 0
Alfred Research Ethic Committee
Ethics committee address [1] 297251 0
The Alfred Hospital
55 Commercial Rd
Melbourne
VIC 3004
Ethics committee country [1] 297251 0
Australia
Date submitted for ethics approval [1] 297251 0
20/03/2017
Approval date [1] 297251 0
11/05/2017
Ethics approval number [1] 297251 0

Summary
Brief summary
The study is to assess the safety and tolerability of PTG300 in normal healthy volunteers.
This includes vital signs, safety labs and physical examinations

Study drug (a single dose of either PTG-300 or placebo, or two doses a week apart) will be given as a subcutaneous injection.

The study will also evaluate the PK of the drug after dose administration, and effects of PTG300 on iron levels.

Participants will be entered into standard study cohorts of 10, 8 active:2 placebo for Cohorts 1 to 6, and 6 (5 active: 1 placebo) for Cohort 7
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73466 0
Dr Jason Lickliter
Address 73466 0
Nucleus Network Ltd
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, 3004
Country 73466 0
Australia
Phone 73466 0
+61 3 9076 8960
Fax 73466 0
Email 73466 0
J.Lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 73467 0
Mr Lucio Tozzi
Address 73467 0
Protagonist Therapeutics, Inc. 7707 Gateway Blvd., Suite 140, Newark, CA 94560
Country 73467 0
United States of America
Phone 73467 0
+1 510 474 0899
Fax 73467 0
Email 73467 0
l.tozzi@ptgx-inc.com
Contact person for scientific queries
Name 73468 0
Mr Lucio Tozzi
Address 73468 0
Protagonist Therapeutics, Inc. 7707 Gateway Blvd., Suite 140, Newark, CA 94560
Country 73468 0
United States of America
Phone 73468 0
+1 510 474 0899
Fax 73468 0
Email 73468 0
l.tozzi@ptgx-inc.com

No information has been provided regarding IPD availability


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.