CompletedPhase 1

ECC5004 RBA FE Study in Healthy Participants

An Open-Label, Randomized, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation (F1) Compared to New Tablet Formulation (F2) of ECC5004 and Food Effects on F1 and F2 of ECC5004 in Healthy Participants

Lead sponsor

Eccogene

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-32•Healthy volunteers

Primary endpoint

•ECC5004 PK parameters

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06268145

Org study IDEC0006

Timeline

Milestones

Study start2024-02-06actual

Study first posted2024-02-20actual

Primary completion2024-03-29actual

Study completion2024-03-29actual

Last update posted2024-07-17actual

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy male and female participants of non-childbearing potential

•Age of 18 to 65 years

•BMI of 18.0 to 32.0 kg/m2

•Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence

•Male participants agree to use contraception, or agree to practice true abstinence

•No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history

•Able to understand and sign and date informed consent

Exclusion criteria

•Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study.

•Concomitant participation in any investigational study of any nature

•Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing

•Serum calcitonin > 20 ng/L

•Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems

•Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC

•History of pancreatitis

•Significant allergic reaction to active ingredients or excipients of the study drug

•Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

ECC5004 PK parameters: AUC0-tlast

Time frame:Up to day 6

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

ECC5004 PK parameters: AUC0-inf

Time frame:Up to day 6

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

ECC5004 PK parameters: Cmax

Time frame:Up to day 6

Cmax

concentration, descriptive

Primary/protocol endpoint

ECC5004 PK parameters: tmax

Time frame:Up to day 6

Tmax

descriptive

Secondary/protocol endpoint

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

Time frame:Up to Day 6

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: AUC0-tau

Time frame:Up to day 6

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: AUC 0-24

Time frame:Up to day 6

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: tlag

Time frame:Up to day 6

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: t1/2

Time frame:Up to day 6

Half-life

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: CL/F

Time frame:Up to day 6

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: AUC(extr)

Time frame:Up to day 6

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.