A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and in Japanese Participants with Type 2 Diabetes Mellitus

JRCT ID: jRCT2051240164

Registered date:17/10/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Healthy Participants
Type 2 Diabetes

• Date of first enrollment: 30/08/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

> Arms (Arm Title/Type/Description)
- Cohort A1-AZD5004/Experimental/Participants will receive AZD5004 orally.
- Cohort A1-Placebo/Placebo Comparator/Participants will receive matching Placebo orally.
- Cohort A2-AZD5004/Experimental/Participants will receive AZD5004 orally.
- Cohort A2-Placebo/Placebo Comparator/Participants will receive matching Placebo orally.
- Cohort A3-AZD5004/Experimental/Participants will receive AZD5004 orally.
- Cohort A3-Placebo/Placebo Comparator/Participants will receive matching Placebo orally.
- Cohort B-AZD5004/Experimental/Participants will receive AZD5004 orally.
- Cohort B-Placebo/Placebo Comparator/Participants will receive matching Placebo orally.

> Interventions (Interventions Name/Type/Associated Arms/Description/Other Names)
- AZD5004(Cohort A1)/Drug/Cohort A1-AZD5004/Single dose of AZD5004 oral on Day1
NOTE: Intervention Other Names have not been specified
- Placebo(Cohort A1)/Drug/Cohort A1-Placebo/Single dose of placebo oral on Day1
NOTE: Intervention Other Names have not been specified
- AZD5004(Cohort A2)/Drug/Cohort A2-AZD5004/Single dose of AZD5004 oral on Day1
NOTE: Intervention Other Names have not been specified
- Placebo(Cohort A2)/Drug/Cohort A2-Placebo/Single dose of placebo oral on Day1
NOTE: Intervention Other Names have not been specified
- AZD5004(Cohort A3)/Drug/Cohort A3-AZD5004/Single dose of AZD5004 oral on Day1
NOTE: Intervention Other Names have not been specified
- Placebo(Cohort A3)/Drug/Cohort A3-Placebo/Single dose of placebo oral on Day1
NOTE: Intervention Other Names have not been specified
- AZD5004(Cohort B)/Drug/Cohort B-AZD5004/AZD5004 will be administered as an oral tablet once daily.
NOTE: Intervention Other Names have not been specified
- Placebo(Cohort B)/Drug/Cohort B-Plocebo/Placebo will be administered as an oral tablet once daily.
NOTE: Intervention Other Names have not been specified

Outcome(s)

Primary Outcome

> Outcome Measure:
AZD5004 safety parameters: adverse events, post-baseline values and changes from baseline over time of clinical laboratory evaluations, vital signs, and ECG parameters

> TimeFrame:
From screening (Day -28) to last follow up visit

> Description:
To investigate the safety and tolerability of AZD5004 following a single administration in healthy participants in SAD and repeated daily administration in participants
with T2DM in MAD

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

> Inclusion Criteria:
- Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.

> Inclusion Criteria for Part A:
- HbA1c 6.0% or less.
- Body weight 50.0 kg or more and BMI within the range 18.0-32.0 kg/m2.

> Inclusion Criteria for Part B:
- HbA1c 6.5% or more and 10.5% or less.
- Not on any other diabetic medications.
- Body weight 60.0 kg or more and BMI within the range 24.0-35.0 kg/m2.

Exclude criteria

- Has a clinically relevant acute or chronic medical condition or disease.

- History of acute pancreatitis and chronic pancreatitis, gallstones.

- Cardiac arrhythmia or ECG morphology abnormalities.

- Abnormal renal function.

- Known clinically significant gastric emptying abnormality

- Significant hepatic disease.

- Uncontrolled thyroid disease

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06529419