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A Study of ZT002 in Healthy Participants

NCT05491421 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ZT002

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Beijing QL Biopharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • QL Biopharmaceutical Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kristi McLendon · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2023-04-28
Completion
2023-04-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491421 on ClinicalTrials.gov