This is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component. Part A (SAD): a total of 24 healthy volunteers are planned to be enrolled across 3 SAD cohorts and will involve the administration of a single subcutaneous (SC) dose of GB-7624 (300 mg, 600 mg, or 1200 mg) or placebo on Day 1 in cohorts A1, A2, and A3. Part B (MAD): a total of 16 healthy volunteers are planned to be enrolled across 2 MAD cohorts and will involve the administration of multiple SC doses of GB-7624 (300 mg on Day 1 and Day 15 or 600 mg on Day1 and Day 15) or placebo in cohorts B1 and B2. The decision to escalate between dose levels in the SAD (Part A) and the MAD (Part B) as well as the decision to proceed from Part A to Part B will be based on safety review committee (SRC) review of prior cohorts, blinded available safety, tolerability and PK data. Study drug will be administered at the study site by trained study site personnel to ensure compliance. The administration of all trial intervention will be recorded in eCRF. Compliance will be assured by direct supervision and witnessing of trial intervention administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Generate Biomedicines Clinical Site
Herston, Queensland, Australia
Composite Outcome: To assess the safety and tolerability of single doses of GB-7624 administered subcutaneously (SC) in healthy volunteers.
Participant incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs),and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
Time frame: Day -1 to Day 360
Composite Outcome: To assess the safety and tolerability of multiple doses of GB-7624 administered SC in healthy volunteers
Participant incidence and severity of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
Time frame: Day -1 to Day 360
To characterise the maximum concentration (Cmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The Cmax of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The Tmax of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The t1/2 of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUClast of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The V/F of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUC of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following single doses of GB-7624 administered SC in healthy volunteers
The AUCinf of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following singles dose of GB-7624 administered SC in healthy volunteers
The CL/F of GB-7624 following single SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the maximum concentration (Cmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The Cmax of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the time to peak drug concentration (Tmax) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The Tmax of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the half-life (t1/2) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The t1/2 of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the curve to last quantifiable timepoint (AUClast) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUClast of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the volume of distribution (V/F) of GB-7624 following a multiple dose of GB-7624 administered SC in healthy volunteers
The V/F of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve (AUC) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUC of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the the area under the plasma concentration-time curve from time zero to infinity (AUCinf) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The AUCinf of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
To characterise the total body clearance from plasma (CL/F) of GB-7624 following multiple doses of GB-7624 administered SC in healthy volunteers
The CL/F of GB-7624 following multiple SC doses in healthy volunteers will be analyzed
Time frame: Day 1 to Day 360
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