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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
Asset
Cotadutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 19-30•Healthy volunteers
Primary endpoints
•Area under the drug concentration curve•Cmax 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Cardiometabolic biomarkers
1 endpointVital signs (systolic and diastolic blood pressure)
Time frame:38 days
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Safety / tolerability / PK
15 endpointsArea under the drug concentration curve
Time frame:48 hours
AUC₀–∞
concentration, descriptive
Maximum observed plasma concentration of MEDI0382
Time frame:48 hours
Cmax
concentration, descriptive
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
Time frame:48 hours
AUC₀–∞
concentration, descriptive
Time to maximum observed plasma drug concentration
Time frame:48 hours
Tmax
descriptive
Terminal phase elimination half-life
Time frame:48 hours
Half-life
descriptive
Apparent clearance
Time frame:48 hours
descriptive
Adverse Events
Time frame:38 days
Treatment-emergent AEs (any)
descriptive, event
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
Time frame:38 days
descriptive
Anti-drug antibody titer
Time frame:38 days
Immunogenicity (ADA)
descriptive
Vital signs (temperature)
Time frame:38 days
descriptive
Anti-drug antibody incidence
Time frame:38 days
Immunogenicity (ADA)
threshold achievement, event
Clinical laboratory assessments (hematology)
Time frame:38 days
descriptive
Vital signs (pulse rate and respiratory rate)
Time frame:38 days
descriptive
componentsHeart rate, change, respiratory rate
Clinical laboratory assessments (serum chemistry)
Time frame:38 days
descriptive
Clinical laboratory assessments (urinalysis)
Time frame:38 days
descriptive
Provenance
Sources
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.