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DiabetesPhase 1NCT06829563

Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D

A Phase 1 study testing RZ-629, Fasted and Fed in people with Diabetes, run by Rezubio Pharmaceuticals Co., Ltd. at 1 site 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

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) biomarkers in single ascending doses (SAD), food effect, and multiple doses studies of RZ-629 in healthy participants and T2D. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
What is being tested?
RZ-629, Fasted and Fed
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
1 siteAustralia
Study dates
30 Jan 2025to 20 Feb 2026
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

Inclusion Criteria: 1. Sign the informed consent form (ICF) before the study, and fully understand the content, process and possible adverse reactions of the trial.

  1. Healthy male or female subjects between the ages of 18 and 65 years, inclusive.
  2. For part 1, part 2 and part 3 in healthy participants, minimum body weight is 50 kg for males, and 45 kg for females, have a BMI of 18 to 32 kg/m2, inclusive. For part 3 in T2D, BMI is between 25 to 40 kg/m2, inclusive.
  3. For part 1, part 2, and part 3 in healthy participants, fasting plasma glucose is between 3.9 mmol/L (70.2 mg/dL) and 6.1 mmol/L (109.8 mg/dL) at screening. For part 3 in T2D, glycosylated hemoglobin A1c (HbA1c) is between 6.5% and 10.5%, inclusive, and FPG ≤ 13.3 mmol/L at screening.
  4. For part 1, part 2, and part 3 in healthy participants, participants are in good health, with no clinically relevant acute or chronic medical conditions or severe diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, respiratory, blood, immune or dermatological systems, as judged by the investigator. For part 3 in T2D, participants are diagnosed with T2DM for more than 1 year, and on a stable dose of dipeptidyl peptidase IV inhibitor (DPP-4i) monotherapy or DPP-4i + Metformin as their only anti-hyperglycemic treatment for at least 3 months prior to the screening visit.
  5. With no clinically significant findings from vital signs measurements, physical examination, clinical laboratory evaluations and 12-lead ECG, as judged by the investigator.
  6. Subjects must be willing to understand and comply with all research procedures and restrictions and be able to communicate effectively with researchers.

Exclusion Criteria: 1. With a specific history of allergies or known to have multiple allergies.

  1. Have experienced acute illnesses within 2 weeks prior to the first dose or are taking concomitant medications.
  2. With a history or current presence of dysphagia or diseases that may potentially interfere with drug absorption or metabolism.
  3. Subjects and their first-degree relatives with a history of diabetes before screening.
  4. With a history of hypoglycemia or with impaired awareness or cognition of hypoglycemic symptoms within 3 months prior to screening.
  5. History of previous corrected QT interval (QTc) prolongation or clinically abnormal electrocardiogram (ECG) finding during screening.
  6. Have undergone major surgery within the past 6 months, or those planning to undergo surgery during the study period.
  7. Have used any medications and dietary supplements within 2 weeks prior to the first dose.
  8. Within 48 h prior to the first dose, have consumed food or beverages containing caffeine, alcohol, or concentrated tea, or those who have consumed special diets and/or purine-rich diets or have other factors that may affect drug absorption, distribution, metabolism, or excretion.
  9. Have received vaccinations within 4 weeks prior to the first dose or plan to receive vaccinations during the trial.
  10. Have participated in other clinical trials within 3 months prior to the first dose, or those planning to participate in other trials during the study period.
  11. Have donated blood and blood products (including plasma) within 3 months prior to the first dose or have experienced non-physiological blood loss of ≥ 400 mL within 6 months.
  12. Have consumed an average of more than 14 units of alcohol per week within the past 12 months prior to screening.
  13. Have smoked more than 5 cigarettes per day within the past 3 months or cannot stop using any tobacco products during the study.
  14. With a history of drug abuse within the past 12 months or positive drug abuse at screening.
  15. With positive results for serology of infectious diseases at screening. 17. Cannot tolerate venipuncture/indwelling needle or have a history of vasovagal syncope.
  16. Subjects deemed unsuitable for participation in this trial by the investigator due to other factors.
  17. With chronic or acute gastrointestinal inflammation. 20. Abnormal liver function tests: ALT or AST > 2×ULN, or TBIL > 1.5×ULN. 21. Use of drugs that may affect glucose metabolism (e.g., systemic steroids, nonselective β-blockers, monoamine oxidase inhibitors) within 1 month prior to screening.

Trial locations and contacts

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

Australia1 site, 1 recruiting
  • CMAX

    Adelaide

    Thomas Polasek, MD, PhD, 0458 162 715, thomas.polasek@cmax.com.au

    Thomas Polasek, MD, PhD

    Recruiting

Other trials in Australia

About this study

Official title: A Phase Ia/Ib, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose/Multiple Dose Study of RZ-629 to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect in Healthy Subjects and T2D Patients.

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) biomarkers in single ascending doses (SAD), food effect, and multiple doses studies of RZ-629 in healthy participants and T2D.

Read the detailed description

This study comprises of 3 parts - Part 1, Part 2, and Part 3.

Part 1 (SAD in healthy participants) - A total of 50 healthy subjects will be allocated to 5 groups in the SAD study. Each group includes 10 subjects (8 subjects will receive RZ-629 and 2 receive placebo). All subjects will check-in on the day before the administration (Day -1) and on Day 1. Each subject in fasted state will be randomly assigned to receive a single oral dose of RZ-629 or placebo. Subjects will remain in the clinical research unit (CRU) through the completion of the safety/tolerability evaluation. The safety review committee (SRC) will review all safety data and blinded summary of available PK data through the safety follow-up and decide to proceed to the next dose level.

Part 2 (food effect in healthy participants) - A total of 12 healthy subjects will be enrolled to FE study. Subjects in the FE group will be divided into subgroup A and subgroup B equally. During period 1, subjects in subgroup A will receive a single oral dose of RZ-629 tablet with 240 mL of water following a fast of at least 10 hours. Water is not allowed 1 h predose until 1 h post dose. Food or drinks are not allowed until 4 h after the dosing. Subjects in subgroup B will received the dose of RZ-629 tablet with 240 mL of water following a standardized high-calorie meal consumed after an overnight fast of at least 10 h. The meal is approximately 500 kcal, composed of approximately 50% carbohydrates, 30% fat, and 20% protein.The high-fat meal should be consumed within 30 minutes. The 25 mg RZ-629 tablet should be administrated 30 minutes after starting the high-calorie meal. Water is not allowed 1 h predose until 1 h post dose. No food or drinks are allowed for 4 hours post-dose for all subjects in subgroup B.

During period 2, administration will be performed in a crossover manner, i.e., subjects in subgroup A will receive the study drug after consuming a high-fat meal, and subjects in subgroup B will receive the study drug under fasting conditions. There is a washout period of 10 days between each dose. Relevant PK and PD sampling, and safety assessments will be completed during the study.

Part 3 (multiple doses in healthy subjects and in T2D patients) - A total of 72 subjects will be recruited with each cohort including 8 subjects for multiple doses in healthy subjects (body mass index [BMI] between 19 and 32 kg/m2, 6 on RZ-629 and 2 on placebo) and 12 subjects for multiple doses in T2D patients (BMI between 25 and 40 kg/m2, 9 on RZ-629 and 3 on placebo). Subjects will check in on Day -2 to Day -1 for healthy subjects and Day -2 for T2DM patients after 28 days of screening.

On Day 1, healthy subjects will be randomly assigned to orally receive the RZ-629 or placebo once daily for a consecutive 7 days. After being evaluated by the investigator, patients will leave the CRU on Day 2 and return to the CRU on Day 5, Day 6, Day 7 and stay until Day 10, for safety and tolerability assessments, and will be discharged with the consent of the investigator. All subjects will return to the CRU for safety follow-up on Day 15 + 2.

T2D patients cohorts will be enrolled after safety assessment of multiple doses study in healthy subjects. T2D patients will be randomly assigned to orally receive RZ-629 or placebo once daily for a consecutive 28 days. After being evaluated by the investigator, patients will leave the CRU on Day 2 and return to the CRU on Day 8, Day 15, and Day 22 for biosample collection and safety examination. They will then return to the CRU on Day 27 and stay until the end of Day 29. All subjects will return to the CRU for safety follow-up on Day 35 + 2.

Conditions
Diabetes
Being tested
RZ-629, Placebo, Fasted, Fed
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • RZ-629Drug

    Administered orally

  • PlaceboDrug

    Administered orally

  • FastedOther

    Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout

  • FedOther

    Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout

Study groups in NCT06829563
Study groupRoleWhat they receive
Part 1 - RZ-629ExperimentalPart 1 - SAD cohorts: participants receiving RZ-629
Receives: Drug: RZ-629
Part 1 - PlaceboPlacebo comparatorPart 1 - SAD cohorts: participants receiving matching placebo
Receives: Drug: Placebo
Part 2 - Food effect (fasted)ExperimentalPart 2 - PK profile of RZ-629 in fasted condition
Receives: Drug: RZ-629; Other: Fasted
Part 2 - Food effect (fed)ExperimentalPart 2 - PK profile of RZ-629 in fed condition
Receives: Drug: RZ-629; Other: Fed
Part 3 - MAD placeboPlacebo comparatorPart 3 - MAD matching placebo
Receives: Drug: Placebo
Part 3 - MAD RZ-629ExperimentalPart 3 - multiple doses of RZ-629 in healthy participants
Receives: Drug: RZ-629
Part 3 - MAD placebo in T2DPlacebo comparatorPart 3 - Multiple doses of matching placebo in T2D
Receives: Drug: Placebo
Part 3 - MAD RZ-629 in T2DExperimentalPart 3 - Multiple doses of RZ-629 in T2D
Receives: Drug: RZ-629

What is being measured

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

  1. Number of participants reporting 1 or more treatment-emergent adverse events

    Safety assessment of RZ-629 treatment evaluated by proportion of participants with adverse events, laboratory tests, vital signs, and ECGs.

    Measured: Baseline to day 7

Secondary outcomes (4)
  1. Area under the concentration-time curve [AUC] of plasma RZ-629

    Collect blood samples to evaluate AUC

    Measured: Baseline to day 7

  2. Maximum concentration [Cmax] of plasma RZ-629

    Collect blood samples to evaluate Cmax

    Measured: Baseline to Day 7

  3. Changes from baseline in insulin and incretins

    Collect blood samples to evaluate changes from baseline in insulin and incretins

    Measured: Baseline to Day 7

  4. Changes in metabolic parameters in multiple doses study in T2D

    Changes from baseline in body weight, blood glucose, HbA1c, and lipid profile in multiple doses study in T2D

    Measured: Day 1 to week 4

Timeline

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

  1. First posted17 Feb 2025
  2. Study start30 Jan 2025
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Feb 2026 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829563
Sponsor's protocol ID
RZ-629-EN-01
Status last verified
Aug 2025
First submitted
22 Jan 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RZ-629, Fasted and Fed in people with Diabetes, run by Rezubio Pharmaceuticals Co., Ltd. at 1 site in Australia.

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

Who may be eligible to take part?

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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Dr. Tang (086-7566881098, yongsong.tang@rezubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants reporting 1 or more treatment-emergent adverse events (time frame: Baseline to day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Aug 2025.

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