This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg respectively, or matching placebo
The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and PK data for each dose level and to make decisions with regards to study progression. A Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to database lock. The SAP will detail the implementation of all the planned statistical analyses in accordance with the principal features stated in the protocol. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
GMA301 Injection administered as a single dose of 1500 mg
GMA301 Injection without GMA301 administered as a single intravenous dose
GMA301 Injection administered as a single dose of 2000 mg
CMAX Clinical Research
Adelaide, South Australia, Australia
Safety and Tolerability
To assess the safety and tolerability of GMA301 Injection following single escalating intravenous (IV) injections in healthy subjects.
Time frame: All AEs (adverse events) will be captured from the time the investigator received the signed ICF (informed consent form) of subjects until study completion ie Day 70
Pharmacokinetics Profile
PK parameters determined is AUC(0-inf)
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is AUC(0-t)
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is C(max)
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is residual area
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is T(max)
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Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is T(1/2 el)
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Pharmacokinetics Profile
PK parameters determined is K(el)
Time frame: Blood PK samples will be collected for analysis during the treatment period at: pre-dose and 4 hours, 8 hours, 24 hours, 72 hours, 168 hours post-dose (Day 7), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 70
Dose for GMA301 Injection for subsequent clinical studies
To identify appropriate doses of GMA301 Injection for subsequent clinical studies
Time frame: All AEs will be captured from the time the investigator received the signed ICF of subjects until study completion ie Day 70