Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 following Single Ascending Dose Administration to Healthy Subjects who are Overweight or Obese

Study identifier:D8750C00001

ClinicalTrials.gov identifier:NCT05511025

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 following Single Ascending Dose Administration to Healthy Subjects who are Overweight or Obese

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6234, Placebo

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 20 Sept 2022

Estimated Primary Completion Date: 19 Dec 2023

Estimated Study Completion Date: 19 Dec 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
(i) Post menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle stimulating hormone (FSH) levels in the post menopausal range.
(ii) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) of 25 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.
For the Japanese cohort(s):
- Participant is a native of Japan; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.
- Have a BMI of 23 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.

Exclusion Criteria

- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study, including:
(i) Gastroparesis (or similar) requiring treatment, or
(ii) Previous surgery of the upper gastrointestinal tract, or
(iii) Cardiovascular disease, including but not limited to sick sinus syndrome, valvular disease, and cardiomyopathy, or
(iv) Neuromuscular or neurogenic disease, or
(v) Severe vitamin D deficiency < 12 ng/dL (as assessed by screening laboratory results or history), or
(vi) Type 1 or type 2 diabetes mellitus.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Any laboratory values with the following deviations:
(i) Alanine aminotransferase > Upper limit of normal (ULN)
(ii) Aspartate aminotransferase > ULN
(iii) eGFR < 60 ml/min/1.73 m2 (calculated using the CKD EPI formula)
(iv) White blood cell count < LLN
(v) Hemoglobin < LLN
(vi) Total calcium or corrected calcium/ionized calcium < LLN or > ULN
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
(i) Systolic Blood pressure (BP) < 90 mmHg or > 140 mmHg.
(ii) Diastolic BP < 50 mmHg or > 90 mmHg.
(iii) Heart rate < 55 or > 85 beats per minute (bpm)
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6234.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within at least 30 days or 5 half-lives (whichever is longer) of the first administration of IMP in this study. The period of exclusion begins 30 days or 5 half-lives after the last visit in the previous study, whichever is the longest.
- Participants who are vegans or have medical dietary restrictions.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

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Arms	Assigned Interventions
Experimental: Cohort 1 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 2 Participants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 3 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 4 Participants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 5 One dose level for SC administration is planned to be investigated for Japanese participants only	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 6 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 7 Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal
Experimental: Cohort 8 Japanese participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection	Drug: AZD6234 Participants will receive a single dose of AZD6234 as a solution via SC or IV injection Drug: Placebo Participants will receive matching volumes of the placebo as a solution via SC or IV injection Combination Product: Acetaminophen Participants will receive a single dose of acetaminophen as part of a meal

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]