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.
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.
- Healthy male or female subjects between the ages of 18 and 65 years, inclusive.
- 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.
- 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.
- 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.
- With no clinically significant findings from vital signs measurements, physical examination, clinical laboratory evaluations and 12-lead ECG, as judged by the investigator.
- 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.
- Have experienced acute illnesses within 2 weeks prior to the first dose or are taking concomitant medications.
- With a history or current presence of dysphagia or diseases that may potentially interfere with drug absorption or metabolism.
- Subjects and their first-degree relatives with a history of diabetes before screening.
- With a history of hypoglycemia or with impaired awareness or cognition of hypoglycemic symptoms within 3 months prior to screening.
- History of previous corrected QT interval (QTc) prolongation or clinically abnormal electrocardiogram (ECG) finding during screening.
- Have undergone major surgery within the past 6 months, or those planning to undergo surgery during the study period.
- Have used any medications and dietary supplements within 2 weeks prior to the first dose.
- 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.
- Have received vaccinations within 4 weeks prior to the first dose or plan to receive vaccinations during the trial.
- 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.
- 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.
- Have consumed an average of more than 14 units of alcohol per week within the past 12 months prior to screening.
- Have smoked more than 5 cigarettes per day within the past 3 months or cannot stop using any tobacco products during the study.
- With a history of drug abuse within the past 12 months or positive drug abuse at screening.
- With positive results for serology of infectious diseases at screening. 17. Cannot tolerate venipuncture/indwelling needle or have a history of vasovagal syncope.
- Subjects deemed unsuitable for participation in this trial by the investigator due to other factors.
- 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
- Recruiting
CMAX
Adelaide
Thomas Polasek, MD, PhD, 0458 162 715, thomas.polasek@cmax.com.au
Thomas Polasek, MD, PhD
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 group | Role | What they receive |
|---|---|---|
| Part 1 - RZ-629 | Experimental | Part 1 - SAD cohorts: participants receiving RZ-629 Receives: Drug: RZ-629 |
| Part 1 - Placebo | Placebo comparator | Part 1 - SAD cohorts: participants receiving matching placebo Receives: Drug: Placebo |
| Part 2 - Food effect (fasted) | Experimental | Part 2 - PK profile of RZ-629 in fasted condition Receives: Drug: RZ-629; Other: Fasted |
| Part 2 - Food effect (fed) | Experimental | Part 2 - PK profile of RZ-629 in fed condition Receives: Drug: RZ-629; Other: Fed |
| Part 3 - MAD placebo | Placebo comparator | Part 3 - MAD matching placebo Receives: Drug: Placebo |
| Part 3 - MAD RZ-629 | Experimental | Part 3 - multiple doses of RZ-629 in healthy participants Receives: Drug: RZ-629 |
| Part 3 - MAD placebo in T2D | Placebo comparator | Part 3 - Multiple doses of matching placebo in T2D Receives: Drug: Placebo |
| Part 3 - MAD RZ-629 in T2D | Experimental | Part 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.
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)
Area under the concentration-time curve [AUC] of plasma RZ-629
Collect blood samples to evaluate AUC
Measured: Baseline to day 7
Maximum concentration [Cmax] of plasma RZ-629
Collect blood samples to evaluate Cmax
Measured: Baseline to Day 7
Changes from baseline in insulin and incretins
Collect blood samples to evaluate changes from baseline in insulin and incretins
Measured: Baseline to Day 7
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.
- First posted17 Feb 2025
- Study start30 Jan 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rezubio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06829563
- Acronym / sponsor ID
- RZ-629-EN-01
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Rezubio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 17 Feb 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 - RZ-629 | Experimental | Drug: RZ-629Part 1 - SAD cohorts: participants receiving RZ-629 |
| Part 1 - Placebo | Placebo comparator | Drug: PlaceboPart 1 - SAD cohorts: participants receiving matching placebo |
| Part 2 - Food effect (fasted) | Experimental | Drug: RZ-629, Other: FastedPart 2 - PK profile of RZ-629 in fasted condition |
| Part 2 - Food effect (fed) | Experimental | Drug: RZ-629, Other: FedPart 2 - PK profile of RZ-629 in fed condition |
| Part 3 - MAD placebo | Placebo comparator | Drug: PlaceboPart 3 - MAD matching placebo |
| Part 3 - MAD RZ-629 | Experimental | Drug: RZ-629Part 3 - multiple doses of RZ-629 in healthy participants |
| Part 3 - MAD placebo in T2D | Placebo comparator | Drug: PlaceboPart 3 - Multiple doses of matching placebo in T2D |
| Part 3 - MAD RZ-629 in T2D | Experimental | Drug: RZ-629Part 3 - Multiple doses of RZ-629 in T2D |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| RZ-629Administered orally | Drug | Part 1 - RZ-629, Part 2 - Food effect (fasted), Part 2 - Food effect (fed), Part 3 - MAD RZ-629, Part 3 - MAD RZ-629 in T2D |
| PlaceboAdministered orally | Drug | Part 1 - Placebo, Part 3 - MAD placebo, Part 3 - MAD placebo in T2D |
| FastedParticipants will be treated with RZ-629 in fasted or fed condition and then cross over after washout | Other | Part 2 - Food effect (fasted) |
| FedParticipants will be treated with RZ-629 in fasted or fed condition and then cross over after washout | Other | Part 2 - Food effect (fed) |
Primary outcome
Number of participants reporting 1 or more treatment-emergent adverse events
Time frame: Baseline to day 7
Safety assessment of RZ-629 treatment evaluated by proportion of participants with adverse events, laboratory tests, vital signs, and ECGs.
4 secondary outcomes
Area under the concentration-time curve [AUC] of plasma RZ-629
Time frame: Baseline to day 7
Maximum concentration [Cmax] of plasma RZ-629
Time frame: Baseline to Day 7
Changes from baseline in insulin and incretins
Time frame: Baseline to Day 7
Changes in metabolic parameters in multiple doses study in T2D
Time frame: Day 1 to week 4
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 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
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.