A Study of ZT002 in Healthy Participants

NCT05491421 | Completed Phase 1 DMC

• 1 other identifier: ZT002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (2)

A (ZT002)

EXPERIMENTAL

Drug: ZT002 Dose level: SAD dose (Cohort 1-4) * 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg; MAD dose (Cohort 1-3) * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings Dose: Subcutaneous Injection

Drug: ZT002

B (Placebo)

PLACEBO COMPARATOR

Dose level: SAD dose (Cohort 1-4) * 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg; MAD dose (Cohort 1-3) * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings Dose: Subcutaneous Injection

Other: Placebo

Interventions

ZT002 DRUG

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

A (ZT002)

Placebo OTHER

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

B (Placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, age 18-55 years, both inclusive, at time of informed consent
• Body Mass Index (BMI) between 22.0～35.0 kg/m2 both included. For the MAD portion only, participants with BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥ 80 kg will be included.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and before administration of study drug, as assessed by the Investigator
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
• Has no relevant dietary restrictions (not including those common restrictions that can be easily accommodated, i.e., veganism, vegetarianism, halal, etc.), and willing to consume standard meals within the options provided by the site
• Male participants must be surgically sterile (\>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the participant must be surgically sterile (\>30 days since vasectomy with no viable sperm) or the participant and his partner must be using an acceptable, highly effective contraceptive method from 4 weeks prior to dosing until study completion, including the follow-up period.
• Female participants that are WOCBP must be non-pregnant and non-lactating, and using an acceptable, highly effective contraceptive method from 4 weeks prior to dosing until study completion, including the follow-up period, OR must be abstinent from heterosexual intercourse OR their partner must be surgically sterile (\>30 days since vasectomy with no viable sperm), provided the male partner is a sole partner.
• Female participants that are not WOCBP must have documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants.
• Acceptable methods of contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: oral contraceptive pill (OCPs), long acting implantable hormones, injectable hormones, contraceptive patches, a vaginal ring or an intrauterine device (IUD).
• Participants with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle, and no contraception is required.
• Male participants agree not to donate sperm for at least 90 days after the last dose of study drug.

You may not qualify if:

• History of significant drug allergy or drug hypersensitivity.
• Known or suspected allergy to trial product or related products.
• eGFR value ≤90 mL/min/1.73m2 using the MDRD equation.
• Clinically significant abnormal laboratory test results during the Screening and before administration of study drug, as judged by the Investigator.
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the participant.
• History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
• History of acute or chronic pancreatitis.
• Calcitonin equal or above 50 ng/L at screening.
• Fever (body temperature \>37.5°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening and Day -1.
• History of severe allergic or anaphylactic reactions.
• QTcF \> 450 ms for male participants or \> 470 ms for female participants, or any other abnormal ECG findings that are considered by the Investigator to be clinically significant, at Screening and before administration of study drug.
• History or presence of a condition associated with significant immunosuppression.
• History of life -threatening infection (e.g. meningitis).
• Infections requiring parenteral antibiotics within the 6 months prior to Screening.
• History of drug/chemical substance abuse within 1 year from Screening.

Sponsors & Collaborators

• QL Biopharmaceutical Australia Pty Ltd: lead
• Novotech (Australia) Pty Limited: collaborator
• Beijing QL Biopharmaceutical Co.,Ltd: collaborator

Study Sites (1)

Q-Pharm Pty Limited

Herston, Queensland, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kristi McLendon

  Nucleus Network Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: September 2, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

AU (1)