HealthyPhase 1NCT07184502

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZT003 Injection Following Single and Multiple Subcutaneous Administration in Healthy Volunteers/Overweight or Obese Volunteers

A Phase 1 study testing ZT003 - Part1 (Single ascending dose ) and ZT003 - Part 2(Multiple ascending dose ) in people with Healthy, run by Beijing QL Biopharmaceutical Co.,Ltd at 2 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ZT003 - Part1 (Single ascending dose ) and ZT003 - Part 2(Multiple ascending dose )
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 2 sitesAustralia
Study dates: 16 Oct 2025to 11 Apr 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male and female participants, aged 18 to 65 years at the time of screening.
Body weight >50 kg to <130 kg, and BMI between 22.0 and 45.0 kg/m square.
Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator.
Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.
Able to understand and comply with study procedures and provide written informed consent.
Thyroid function tests within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.

Who cannot join

History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
History of drug or alcohol abuse within 12 months prior to screening.
Use of prescription drugs, over-the-counter medications, herbal products, or supplements within 14 days (or 5 half-lives) prior to first dose unless deemed acceptable by the Investigator.
Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.
Any history of significant allergy or hypersensitivity to any component of the investigational medicinal product (IMP).

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Clinically significant ECG abnormalities, including QTc >450 ms (males) or >470 ms (females) at screening.
Abnormal clinical laboratory results at screening considered clinically significant by the Investigator.
History of bleeding disorders or current use of anticoagulant therapy.
Pregnant or lactating females, or females planning to become pregnant during the study period.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Zhao contact

+86 13581948820

Ruihua@qlbiopharm.com

Australia2 sites, 2 recruiting

Nucleus Network Brisbane
Brisbane, Queensland
Gloria Wong, Dr
Recruiting
Nucleus Network
Melbourne
Dr Aarthy Joseph
Aarthy Joseph
Not yet recruiting

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZT003 Injection in Healthy Volunteers and Overweight or Obese Volunteers

Read the detailed description

This is a first-in-human, Phase 1, randomized, single-center, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of ZT003 following subcutaneous administration in healthy adult participants. The study is designed in two parts:

Part A (Single Ascending Dose [SAD]): Approximately 48 participants will be enrolled into sequential dose cohorts. Each cohort will receive a single dose of ZT003 or matching placebo administered subcutaneously. Dose escalation will proceed based on safety, tolerability, and pharmacokinetic data from the preceding cohorts.

Part B (Multiple Ascending Dose [MAD]): Approximately 24 participants will be enrolled into sequential cohorts. Each participant will receive multiple subcutaneous doses of ZT003 or placebo. Dosing frequency and duration will be based on data obtained from Part A and guided by predefined criteria.

The study will evaluate safety through the monitoring of adverse events, clinical laboratory tests, vital signs, physical examinations, ECGs, and injection site assessments. Pharmacokinetic parameters will be measured using plasma drug concentration profiles. The results from this study will inform dose selection and design for future clinical studies in patient populations.

Conditions: Healthy
Being tested: ZT003 - Part1 (Single ascending dose ), ZT003 - Part 2(Multiple ascending dose )

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZT003 - Part1 (Single ascending dose )Drug
ZT003 or Placeo is administered as a single subcutaneous injection at different dose levels.
ZT003 - Part 2(Multiple ascending dose )Drug
ZT003 or Placeo administered as multiple subcutaneous injections at different dose levels.

Study groups in NCT07184502
Study group	Role	What they receive
Up to 6 Single Ascending Dose (SAD) Cohorts - ZT003 with Placebo	Experimental	Participants will receive a single subcutaneous dose of ZT003 at ascending dose levels across up to 6 cohorts in 3:1 Ratio Receives: Drug: ZT003 - Part1 (Single ascending dose )
Up to 2 Multiple Ascending Dose (MAD) Cohorts - ZT003 with Placebo	Experimental	Participants will receive multiple subcutaneous doses of ZT003 at ascending dose levels across up to 2 cohorts in 3:1 Ratio Receives: Drug: ZT003 - Part 2(Multiple ascending dose )

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Serious Adverse Events (SAEs)
Measured: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events of Special Interest (AESIs)
Measured: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal
Measured: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence and Severity of Injection Site Reactions (ISRs)
Measured: From first dose (Day 1) through End of Treatment/EOT visit (Day 50)
Change from Baseline in Systolic Blood Pressure
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Diastolic Blood Pressure
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Pulse Rate
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Body Temperature
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Respiratory Rate
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Heart Rate
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG PR Interval
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QRS Duration
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QT Interval
Measured: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Corrected QT Interval (QTcF)
Measured: From Screening (Day -35) through End of Treatment (Day 50).

Secondary outcomes (8)

Plasma Cmax of ZT003
Measured: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
Plasma Tmax of ZT003
Measured: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
AUC from time zero to the last quantifiable concentration of ZT003
Measured: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
AUC from time zero extrapolated to infinity of ZT003
Measured: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Plasma half-life (t½) of ZT003
Measured: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Clearance (CL/F) of ZT003
Measured: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Volume of Distribution (Vz/F) of ZT003
Measured: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Presence of Anti-Drug Antibodies (ADA)
Measured: Baseline, Day 29, Day 57, and End of Study (Day 50)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 202511 Apr 2027

First posted22 Sep 2025
Study start16 Oct 2025
Primary completion24 Dec 2026 (estimated)
Study completion11 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07184502
Sponsor's protocol ID: BJQL-ZT003-1001
Status last verified: Jan 2026
First submitted: 19 Aug 2025
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Ruihua Zhao

+86 13581948820

Ruihua@qlbiopharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZT003 Injection in Healthy Volunteers and Overweight or Obese Volunteers
ClinicalTrials.gov ID: NCT07184502
Acronym / sponsor ID: BJQL-ZT003-1001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 72 participants (estimated)
Lead sponsor: Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
Study start: 16 Oct 2025 (actual)
Primary completion: 24 Dec 2026 (estimated)
Study completion: 11 Apr 2027 (estimated)
First posted: 22 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Up to 6 Single Ascending Dose (SAD) Cohorts - ZT003 with Placebo	Experimental	Drug: ZT003 - Part1 (Single ascending dose )Participants will receive a single subcutaneous dose of ZT003 at ascending dose levels across up to 6 cohorts in 3:1 Ratio
Up to 2 Multiple Ascending Dose (MAD) Cohorts - ZT003 with Placebo	Experimental	Drug: ZT003 - Part 2(Multiple ascending dose )Participants will receive multiple subcutaneous doses of ZT003 at ascending dose levels across up to 2 cohorts in 3:1 Ratio

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy male and female participants, aged 18 to 65 years at the time of screening.
Body weight >50 kg to <130 kg, and BMI between 22.0 and 45.0 kg/m square.
Medically healthy, with no clinically significant abnormalities in medical history, physical examination, vital signs, ECG, or clinical laboratory assessments, as judged by the Investigator.
Females of childbearing potential must use highly effective contraception and have a negative pregnancy test at screening and Day -1.
Male participants must agree to use acceptable contraception from screening through at least 90 days after the last dose.

Key exclusion criteria (10 listed)

History or presence of any clinically significant disease or disorder that may put the participant at risk or interfere with study assessments.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or HIV antibody at screening.
History of drug or alcohol abuse within 12 months prior to screening.
Use of prescription drugs, over-the-counter medications, herbal products, or supplements within 14 days (or 5 half-lives) prior to first dose unless deemed acceptable by the Investigator.
Participation in another clinical study with an investigational product within 30 days or 5 half-lives of the investigational product before dosing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZT003 - Part1 (Single ascending dose )ZT003 or Placeo is administered as a single subcutaneous injection at different dose levels.	Drug	Up to 6 Single Ascending Dose (SAD) Cohorts - ZT003 with Placebo
ZT003 - Part 2(Multiple ascending dose )ZT003 or Placeo administered as multiple subcutaneous injections at different dose levels.	Drug	Up to 2 Multiple Ascending Dose (MAD) Cohorts - ZT003 with Placebo

Primary outcome

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Serious Adverse Events (SAEs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence of Adverse Events Leading to Study Drug Discontinuation or Withdrawal
Time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).
Incidence and Severity of Injection Site Reactions (ISRs)
Time frame: From first dose (Day 1) through End of Treatment/EOT visit (Day 50)
Change from Baseline in Systolic Blood Pressure
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Diastolic Blood Pressure
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Pulse Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Body Temperature
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in Respiratory Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Heart Rate
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG PR Interval
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QRS Duration
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG QT Interval
Time frame: From Screening (Day -35) through End of Treatment (Day 50).
Change from Baseline in ECG Corrected QT Interval (QTcF)
Time frame: From Screening (Day -35) through End of Treatment (Day 50).

8 secondary outcomes

Plasma Cmax of ZT003
Time frame: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
Plasma Tmax of ZT003
Time frame: Day 1 to 24 hours post-dose (SAD); pre-dose to 24 hours post-final dose (MAD)
AUC from time zero to the last quantifiable concentration of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
AUC from time zero extrapolated to infinity of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Plasma half-life (t½) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Clearance (CL/F) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Apparent Volume of Distribution (Vz/F) of ZT003
Time frame: SAD: Day 1 to 96 hours post-dose; MAD: Pre-dose on Days 1, 8, 15, 22, and 29 to 96 hours post-final dose (Day 29), and at End of Treatment (Day 50).
Presence of Anti-Drug Antibodies (ADA)
Time frame: Baseline, Day 29, Day 57, and End of Study (Day 50)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ruihua Zhao contact

+86 13581948820

Ruihua@qlbiopharm.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruihua Zhao (+86 13581948820, Ruihua@qlbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Collected at every visit (Screening, Day -1, Day 1 pre- and post-dose, Days 2-7, and follow-ups at Days 8, 15, 22, 29, and 36).). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07184502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.