A Phase 1 interventional study of ZT002 and Placebo in Type 2 Diabetes Mellitus, sponsored by QL Biopharmaceutical Australia Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by QL Biopharmaceutical Australia Pty Ltd · Phase 1, Interventional, and Treatment
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.
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
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with QL Biopharmaceutical Australia Pty Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Regular alcohol consumption (by self-declaration) in the past 6 months, defined as greater than 21 alcohol units per week for males and 14 units per week for females (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
Unwilling to abstain from alcohol consumption from 24 hours prior to admission to the CRU, during the residency period, and 24 hours prior to each non-residential visit.
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
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
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
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Upto 85 days
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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 85 days
The anti-drug antibody (ADA) response through an anti-drug antibody assay in SAD and MAD cohorts.
Time frame: 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.
Time frame: Up to 85 days
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.