| Trial ID: | L2820 |
| Source ID: | NCT06423872
|
| Associated Drug: |
Zt002
|
| Title: |
A SAD Study of ZT002 Injection in Healthy Participants
|
| Acronym: |
|
| Status: |
COMPLETED
|
| 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 50 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 50 days | Secondary: The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts., Parameter: Maximum observed plasma concentration of ZT002 (Cmax), Up to 50 days|The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD Cohorts., Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last), Up to 50 days|The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD cohorts., Parameter: Area under the drug-time curve to infinity (AUC0-inf), Up to 50 days
|
| Sponsor/Collaborators: |
Sponsor: Beijing QL Biopharmaceutical Co.,Ltd | Collaborators: Beijing Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-06-19
|
| Completion Date: |
2023-12-08
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-21
|
| Locations: |
Beijing Hospital, Beijing, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06423872
|
