This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
This study is planned to be conducted in 2 portions: single ascending dose and multiple ascending doses. For the SAD portion, there are a total of 4 cohorts. In each cohort 6 participants will receive ZT002, and 2 participants will receive placebo, for a total of 8 participants in each cohort. For the MAD portion, the study is planned to be conducted in healthy participants with a BMI range of 26kg/m\^2 to 40kg/m\^2 and a body weight of \>/= 80kg. This portion is planned to be conducted in 3 cohorts (Cohort 1 to 3), 6 participants will receive ZT002, and 2 participants will receive placebo, across of total of 8 participants (for a total of 24 participants across 3 cohorts). In each cohort, 3 escalating doses of ZT002 are planned. Dosing is planned to be administered every 2 weeks (Q2W). Potential participants will be screened to assess their eligibility to enter the study in a Screening period from days -28 to -2, prior to the scheduled treatment on Day 1. A Safety Monitoring Committee (SMC) meeting to discuss dose escalation will be held after each cohort
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Participants will receive a single subcutaneous (SC) ZT002 dose of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under fasted conditions. Participants will MAD Cohorts will receive a single subcutaneous (SC) ZT002 in following doses under fasting conditions- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings
Participants will receive same volume as of the study drug of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under the fasted condition. Participants in MAD cohorts will receive same volume as study drug in the following cohorts under fasted condition- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings
Q-Pharm Pty Limited
Herston, Queensland, Australia
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Up to 71 days
Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Up to 71 days
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through number of participants with treatment emergent adverse events in MAD Cohorts.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: up to 85 days
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through incidence severity of serious adverse events in MAD Cohorts.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Upto 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Maximum observed plasma concentration of ZT002 (Cmax)
Time frame: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last)
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Time frame: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD cohorts. Parameter: Area under the drug-time curve to infinity (AUC0-inf)
Time frame: Up to 85 days
The anti-drug antibody (ADA) response through an anti-drug antibody assay in SAD and MAD cohorts.
Time frame: Up to 85 days
The anti-drug antibody (ADA) response through testing serum or plasma of the participant post dosing in SAD and MAD cohorts.
Time frame: Up to 85 days