This study is a first-in-human (FIH), randomized, double-blind, placebo-controlled study of PMG1016 in healthy adult participants. It aims to investigate the safety, tolerability, PK, and immunogenicity of PMG1016 administered via IV infusion. Cohort 1: Healthy participants receiving single doses of PMG1016 Dose 1 or placebo. Cohort 2: Healthy participants receiving single doses of PMG1016 Dose 2 or placebo. Cohort 3: Healthy participants receiving single doses of PMG1016 Dose 3 or placebo. Cohort 4: Healthy participants receiving single doses of PMG1016 Dose 4 or placebo.
Participants will be enrolled and randomized into 1 of 4 cohorts in a double-blind manner
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Participants will be administered PMG1016 Dose 1 or Placebo in a 100mL IV infusion Volume
Participants will be administered PMG1016 Dose 2 or Placebo in a 100mL IV infusion Volume
Participants will be administered PMG1016 Dose 3 or Placebo in a 100mL IV infusion Volume
Participants will be administered PMG1016 Dose 4 or Placebo in a 100mL IV infusion Volume
Nucleus Network (Brisbane)
Brisbane, Queensland, Australia
RECRUITINGTreatment-emergent adverse events (TEAEs)
The incidence and severity occurred
Time frame: Day 1 to Day 57
Serious adverse events (SAEs)
The incidence and severity occurred
Time frame: From Day 1 to Day 57
Number of participants with abnormal pulse rate
Time frame: From Day 1 to Day 57
Number of participants with abnormal blood pressure
Time frame: From Day 1 to Day 57
Number of participants with abnormal respiratory rate
Time frame: From Day 1 to Day 57
Number of participants with abnormal tympanic temperature
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal PR Interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QRS Duration
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal QT interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal RR interval
Time frame: From Day 1 to Day 57
Number of Participants with Clinically Significant Valvular Abnormalities
The number of participants with clinically significant valvular abnormalities identified by transthoracic echocardiography (TTE)
Time frame: Day 1 to Day 29
Number of Participants with Clinically Significant Abnormal Left Ventricular Ejection Fraction
The number of participants with clinically significant abnormalities in left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography (TTE)
Time frame: Day 1 to Day 29
Number of Participants with Clinically Significant Abnormal Hematology Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Clinical Chemistry Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Urinalysis Results
Time frame: Day 1 to Day 57
Number of Participants with Clinically Significant Abnormal Physical Examination Findings
assessment of general appearance; head; ears; eyes; nose; throat; dentition; thyroid; chest (heart and lungs); abdomen; skin; neurological system; extremities; back; neck; musculoskeletal system; and lymph nodes
Time frame: Day 1 to Day 57
Incidence of anti-drug antibodies (ADA)
Percentage of PMG1016-induced ADA positive participants and percentage of PMG1016-boosted ADA positive participants
Time frame: From Day 1 to Day 57
Maximum serum PMG1016 concentration (Cmax)
Determine PMG1016 Cmax in Serum
Time frame: Varying timepoints through end of treatment, up to Day 57
Time to maximum concentration (Tmax)
Determine PMG1016 Tmax in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
Area under the serum drug concentration-time curve (AUC) from time zero to the last time point with measurable concentration (AUC0-t)
Determine PMG1016 AUC and AUC0-t in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
AUC from time zero to infinity (AUC0-∞)
Determine PMG1016 AUC0-∞ in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
The extrapolated portion of AUC0-∞ from Tlast to infinity (%AUCextrap)
Determine PMG1016 %AUCextrap in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
Terminal elimination half-life (t1/2)
Determine PMG1016 t1/2 in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent total body clearance (CL)
Determine PMG1016 CL in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent volume of distribution during the terminal phase (Vz)
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Determine PMG1016 Vz in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57
Apparent terminal elimination rate constant (λz)
Determine PMG1016 λz in Serum.
Time frame: Varying timepoints through end of treatment, up to Day 57