This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) parts.
This is a first-in-human, Phase 1, randomized, single-center, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study is designed in two parts: Part A (Single Ascending Dose \[SAD\]): Approximately 48 participants will be enrolled into sequential dose cohorts. Each cohort will receive a single dose of ZT003 or matching placebo administered subcutaneously. Dose escalation will proceed based on safety, tolerability, and pharmacokinetic data from the preceding cohorts. Part B (Multiple Ascending Dose \[MAD\]): Approximately 24 participants will be enrolled into sequential cohorts. Each participant will receive multiple subcutaneous doses of ZT003 or placebo. Dosing frequency and duration will be based on data obtained from Part A and guided by predefined criteria. The study will evaluate safety through the monitoring of adverse events, clinical laboratory tests, vital signs, physical examinations, ECGs, and injection site assessments. Pharmacokinetic parameters will be measured using plasma drug concentration profiles. The results from this study will inform dose selection and design for future clinical studies in patient populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
ZT003 or Placeo is administered as a single subcutaneous injection at different dose levels.
ZT003 or Placeo administered as multiple subcutaneous injections at different dose levels.
Nucleus Network Brisbane
Brisbane, Queensland, Australia
RECRUITINGNucleus Network
Melbourne, Australia
NOT_YET_RECRUITINGIncidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Serious Adverse Events (SAEs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence and Severity of Injection Site Reactions (ISRs)
Time frame: From first dose (Day 1) through End of Treatment/EOT visit (Day 50)
Change from Baseline in Systolic Blood Pressure
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Diastolic Blood Pressure
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Pulse Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Body Temperature
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Respiratory Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Heart Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG PR Interval
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QRS Duration
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QT Interval
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Corrected QT Interval (QTcF)
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Plasma Cmax of ZT003
Time frame: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
Plasma Tmax of ZT003
Time frame: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
AUC from time zero to the last quantifiable concentration of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
AUC from time zero extrapolated to infinity of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Plasma half-life (t½) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Clearance (CL/F) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Volume of Distribution (Vz/F) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Presence of Anti-Drug Antibodies (ADA)
Time frame: Baseline, Day 29, Day 57, and End of Study (Day 50)
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