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CompletedPhase 1

A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382

A Phase 1, Randomized, Cross-over, Two-period Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382 in Healthy Adult Subjects

Lead sponsor

MedImmune LLC

Asset

Cotadutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

24

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 19-30Healthy volunteers

Primary endpoints

Area under the drug concentration curveCmax of MEDI0382

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03341013
Org study IDD5670C00003

Timeline

Milestones

Study first posted2017-11-14actual
Study start2017-11-30actual
Primary completion2018-01-29actual
Study completion2018-01-29actual
Last update posted2018-02-14actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Healthy subjects age 18 through 45 years at the time of screening.

2. Provision of signed and dated written informed consent prior to study-specific procedures.

3. Body mass index between 19 and 30 kg/m2 (inclusive) at screening

4. Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG, vital signs, and blood and urinary laboratory assessments.

5. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.

6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use a male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Exclusion criteria

1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate, or affect the interpretation of the results of the study

2. Impaired renal function, defined as s-creatinine ≥ 130 µmol/L

3. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2

4. Blood pressure and heart rate in supine position outside the ranges of 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min following a 10-minute rest period.

5. Any clinically significant abnormal ECG, as judged by the investigator

6. Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests

7. Positive human immunodeficiency virus antibodies

8. Known or suspected allergy to MEDI0382, any component of the formulation, or related products

9. Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in

10. History of alcoholism or drug abuse during the last 12 months

11. Smoking of cigarettes or other tobacco products

12. Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator

13. Blood donation within the last 3 months

14. Participation in any other trial investigating other products or involving blood sampling within the past 30 days

15. Potentially noncompliant or uncooperative, as judged by the investigator

16. Substance dependence likely to impact subject safety or compliance with study procedures

17. Psychiatric illness such that subjects have been committed to an institution by way of official or judicial order

18. Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study site employee or their close relatives

Endpoints (16)

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.

Coverage by outcome category

Safety / tolerability / PK
15
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Vital signs (systolic and diastolic blood pressure)

Time frame:38 days

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

15 endpoints
Primary/protocol endpoint

Area under the drug concentration curve

Time frame:48 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed plasma concentration of MEDI0382

Time frame:48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma drug concentration versus time curve from zero to infinity and to last observation

Time frame:48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed plasma drug concentration

Time frame:48 hours

Tmax

descriptive

Secondary/protocol endpoint

Terminal phase elimination half-life

Time frame:48 hours

Half-life

descriptive

Secondary/protocol endpoint

Apparent clearance

Time frame:48 hours

descriptive

Secondary/protocol endpoint

Adverse Events

Time frame:38 days

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals

Time frame:38 days

descriptive

Secondary/protocol endpoint

Anti-drug antibody titer

Time frame:38 days

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Vital signs (temperature)

Time frame:38 days

descriptive

Secondary/protocol endpoint

Anti-drug antibody incidence

Time frame:38 days

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Clinical laboratory assessments (hematology)

Time frame:38 days

descriptive

Secondary/protocol endpoint/low confidence

Vital signs (pulse rate and respiratory rate)

Time frame:38 days

descriptive

componentsHeart rate, change, respiratory rate

Secondary/protocol endpoint

Clinical laboratory assessments (serum chemistry)

Time frame:38 days

descriptive

Secondary/protocol endpoint

Clinical laboratory assessments (urinalysis)

Time frame:38 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.