| Trial ID: | L5098 |
| Source ID: | NCT05491421
|
| Associated Drug: |
Zt002
|
| Title: |
A Study of ZT002 in Healthy Participants
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: ZT002|OTHER: Placebo
|
| Outcome Measures: |
Primary: 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)., 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)., 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)., 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)., Upto 85 days | Secondary: 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), 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), 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), Up to 85 days|The anti-drug antibody (ADA) response through an anti-drug antibody assay in SAD and MAD cohorts., 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., Up to 85 days
|
| Sponsor/Collaborators: |
Sponsor: QL Biopharmaceutical Australia Pty Ltd | Collaborators: Novotech (Australia) Pty Limited|Beijing QL Biopharmaceutical Co.,Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-09-02
|
| Completion Date: |
2024-04-14
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| Results First Posted: |
|
| Last Update Posted: |
2023-05-16
|
| Locations: |
Q-Pharm Pty Limited, Herston, Queensland, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT05491421
|
