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

NCT06829563 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RZ-629-EN-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (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.

  Baseline to day 7

Secondary Outcomes (4)

• Area under the concentration-time curve [AUC] of plasma RZ-629

  Baseline to day 7

• Maximum concentration [Cmax] of plasma RZ-629

  Baseline to Day 7

• Changes from baseline in insulin and incretins

  Baseline to Day 7

• Changes in metabolic parameters in multiple doses study in T2D

  Day 1 to week 4

Study Arms (8)

Part 1 - RZ-629

EXPERIMENTAL

Part 1 - SAD cohorts: participants receiving RZ-629

Drug: RZ-629

Part 1 - Placebo

PLACEBO COMPARATOR

Part 1 - SAD cohorts: participants receiving matching placebo

Drug: Placebo

Part 2 - Food effect (fasted)

EXPERIMENTAL

Part 2 - PK profile of RZ-629 in fasted condition

Drug: RZ-629; Other: Fasted

Part 2 - Food effect (fed)

EXPERIMENTAL

Part 2 - PK profile of RZ-629 in fed condition

Drug: RZ-629; Other: Fed

Part 3 - MAD placebo

PLACEBO COMPARATOR

Part 3 - MAD matching placebo

Drug: Placebo

Part 3 - MAD RZ-629

EXPERIMENTAL

Part 3 - multiple doses of RZ-629 in healthy participants

Drug: RZ-629

Part 3 - MAD placebo in T2D

PLACEBO COMPARATOR

Part 3 - Multiple doses of matching placebo in T2D

Drug: Placebo

Part 3 - MAD RZ-629 in T2D

EXPERIMENTAL

Part 3 - Multiple doses of RZ-629 in T2D

Drug: RZ-629

Interventions

RZ-629 DRUG

Administered orally

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

Placebo DRUG

Administered orally

Part 1 - Placebo; Part 3 - MAD placebo; Part 3 - MAD placebo in T2D

Fasted OTHER

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

Part 2 - Food effect (fasted)

Fed OTHER

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

Part 2 - Food effect (fed)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Rezubio Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

CMAX

Adelaide, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Dr. Tang

CONTACT

086-7566881098; yongsong.tang@rezubio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participants, the investigator, the clinic personnel, the bioanalytical laboratory staff, and other study-related personnel will remain blinded to all randomization assignments. Selected individuals not involved in conducting this trial, including Institutional Review Board (IRB) members, may have access to the unblinded data as needed for safety or other data review.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 17, 2025
• Study Start: January 30, 2025
• Primary Completion: December 20, 2025
• Study Completion: February 20, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)