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COMPLETEDPHASE1

A Study of ZT002 in Healthy Participants

A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants

NCT05491421•QL Biopharmaceutical Australia Pty Ltd

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female, age 18-55 years, both inclusive, at time of informed consent
•2. 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.
•3. 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
•4. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
•5. 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
•6. 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.
+1 more criteria

Exclusion Criteria

•1. History of significant drug allergy or drug hypersensitivity.
•2. Known or suspected allergy to trial product or related products.
•3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee), that could adversely affect the safety of the participant or their likelihood to comply with the protocol or complete the study per protocol. Fully resolved childhood asthma is not exclusionary. Gestational diabetes is exclusionary.
•4. eGFR value ≤90 mL/min/1.73m2 using the MDRD equation.
•5. Clinically significant abnormal laboratory test results during the Screening and before administration of study drug, as judged by the Investigator.
•6. Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the participant.
•7. 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.
•8. History of acute or chronic pancreatitis.
•9. Calcitonin equal or above 50 ng/L at screening.
•10. Fever (body temperature \>37.5°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening and Day -1.
+23 more criteria

Locations (1)

Q-Pharm Pty Limited

Herston, Queensland, Australia

Key Dates

Start Date

September 2, 2022

Primary Completion Date

April 28, 2023

Completion Date

April 28, 2023

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

ZT002

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ZT002 in Healthy Participants

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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