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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06829563




Registration number
NCT06829563
Ethics application status
Date submitted
22/01/2025
Date registered
25/03/2025

Titles & IDs
Public title
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects
Scientific title
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of RZ-629 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Subjects
Secondary ID [1] 0 0
RZ-629-EN-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RZ-629
Treatment: Drugs - Placebo

Experimental: RZ-629 - SAD cohorts 1 to 5: participants receiving RZ-629

Placebo comparator: Placebo - SAD cohorts 1 to 5: participants receiving matching placebo


Treatment: Drugs: RZ-629
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants reporting 1 or more treatment-emergent adverse events
Timepoint [1] 0 0
Baseline to day 7
Secondary outcome [1] 0 0
Area under the concentration-time curve [AUC] of plasma RZ-629
Timepoint [1] 0 0
Baseline to day 7
Secondary outcome [2] 0 0
Maximum concentration [Cmax] of plasma RZ-629
Timepoint [2] 0 0
Baseline to Day 7
Secondary outcome [3] 0 0
Changes from baseline in insulin and incretins
Timepoint [3] 0 0
Baseline to Day 7

Eligibility
Key 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.

2. Healthy male or female subjects between the ages of 18 and 65 years, inclusive.

3. With a minimum body weight of 50 kg for males, and 45 kg for females, have a BMI of 18 to 32 kg/m2, inclusive.

4. Fasting plasma glucose is between 3.9 mmol/L (70.2 mg/dL) and 6.1 mmol/L (109.8 mg/dL) at screening.

5. 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.

6. With no clinically significant findings from vital signs measurements, physical examination, clinical laboratory evaluations and 12-lead ECG, as judged by the investigator.

7. Subjects must be willing to understand and comply with all research procedures and restrictions and be able to communicate effectively with researchers.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. With a specific history of allergies or known to have multiple allergies.

2. Have experienced acute illnesses within 2 weeks prior to the first dose or are taking concomitant medications.

3. With a history or current presence of dysphagia or diseases that may potentially interfere with drug absorption or metabolism.

4. Subjects and their first-degree relatives with a history of diabetes before screening.

5. With a history of hypoglycemia or with impaired awareness or cognition of hypoglycemic symptoms within 3 months prior to screening.

6. History of previous corrected QT interval (QTc) prolongation or clinically abnormal electrocardiogram (ECG) finding during screening.

7. Have undergone major surgery within the past 6 months, or those planning to undergo surgery during the study period.

8. Have used any medications and dietary supplements within 2 weeks prior to the first dose.

9. 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.

10. Have received vaccinations within 4 weeks prior to the first dose or plan to receive vaccinations during the trial.

11. 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.

12. 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.

13. Have consumed an average of more than 14 units of alcohol per week within the past 12 months prior to screening.

14. Have smoked more than 5 cigarettes per day within the past 3 months or cannot stop using any tobacco products during the study.

15. With a history of drug abuse within the past 12 months or positive drug abuse at screening.

16. With positive results for serology of infectious diseases at screening. 17. Cannot tolerate venipuncture/indwelling needle or have a history of vasovagal syncope.

18. Subjects deemed unsuitable for participation in this trial by the investigator due to other factors.

19. 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 ß-blockers, monoamine oxidase inhibitors) within 1 month prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rezubio Pharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Tang
Address 0 0
Country 0 0
Phone 0 0
086-7566881098
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06829563