Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
A Randomized, Double-blinded Trial of Single Ascending Doses of ZP4207 Administered s.c. or i.m. to HV and a SD of ZP4207 Administered s.c. to Hypoglycemic T1D to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207 as Compared to an Active Comparator
Lead sponsor
Asset
Dasiglucagon
Subcutaneous · Glucagon receptor agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
111
Study population
Prediabetes / glucose intolerance
Eligibility highlights
•HbA1c ≤8.5%•Male•Healthy volunteers
Primary endpoint
•Safety and Tolerability
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
2. Male subjects which are healthy for part 1; for part 2 male subjects with T1D
3. Age between 18 and 50 years, both inclusive.
4. Body weight between 70 and 90 kg, both inclusive.
5. Subjects must be in good health according to age (medical history, physical examination, vital signs, ECG, lab assessments), as judged by the investigator
6. A subject who is surgically sterilized or must be willing to refrain from sexual intercourse during the trial and until one month after completion of the trial or if sexually active, using condom and partner practices contraception during the trial and until one month after completion of the trial.
For part 2, in addition:
7. Male subjects with T1D for at least one year, as defined by the American Diabetes Association.
8. Having been treated with insulin for T1D for at least 1 year.
9. Stable disease with HbA1c < 8.5 %.
10. Stable insulin treatment during participation in trial and 3 month prior to the screening visit.
Exclusion criteria
1. Known or suspected allergy to trial product(s) or related products.
2. Previous participation (randomization) in this trial.
3. Receipt of any investigational drug within 3 months prior to screening.
4. A history or presence of cancer, diabetes (part 1 only), or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases.
5. Clinically significant illness within 4 weeks before screening, as judged by the investigator
6. Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies.
7. Positive result of test for HIV antibodies.
8. Any clinically significant abnormal hematology,biochemistry or urinalysis screening tests, as judged by the Investigator.
9. Clinically significant abnormal ECG at screening as evaluated by Investigator.
10. Donation of blood or plasma in the past month, or in excess of 500 ml within 12 weeks prior to screening.
11. A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer, 1 glass of wine, or 20 ml of spirits).
12. Habitual smoking, i.e., daily smoking or more than 7 cigarettes/week within the last 3 months prior to screening. Subjects have to accept refraining from smoking while at the clinical site.
13. Subjects with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the Investigator should not participate in the trial.
14. Surgery or trauma with significant blood loss within the last 2 months prior to screening.
15. Any condition interfering with trial participation or evaluation or that may be hazardous to the subject.
For part 2, in addition
16. Severe hypoglycemic events within one year prior to screening, as judged by the investigator.
17. Significant changes in basal insulin within 3 weeks before screening, as judged by the investigator.
18. Clinically relevant diabetic complications (macrovascular disease with symptoms of coronary artery disease or peripheral vascular disease, microvascular disease with symptoms of neuropathy, gastroparesis, retinopathy, nephropathy, or poor blood glucose control with polyuria, polydipsia, or weight loss), as judged by the investigator.
Endpoints (18)
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
Glycemic / diabetes
2 endpointsPharmacodynamics (PD): Area under the Plasma glucose curve from time-point 0 until 300 min (AUCgluc 0-300)
Time frame:5 hours
concentration, descriptive
Pharmacodynamics: Time to plasma glucose equal or above (70 mg/dL)
Time frame:5 hours
time to event, event
Safety / tolerability / PK
16 endpointsSafety and Tolerability: Number of participants with adverse events
Time frame:28 days
event count, event
Safety and Tolerability: Changes or findings from baseline in clinical safety laboratory assessments
Time frame:28 days
descriptive
Safety and Tolerability: Changes or findings from baseline in physical examination
Time frame:28 days
descriptive
Safety and Tolerability: Changes or findings from baseline in vital signs
Time frame:28 days
descriptive
Safety and Tolerability: Changes or findings from baseline in ECG
Time frame:28 days
descriptive
Safety and Tolerability: Findings in local tolerability
Time frame:28 days
descriptive
Pharmacokinetics (PK): Area under the curve (AUC) from time-point 0 until 300min
Time frame:5 hours
concentration, descriptive
Pharmacokinetics: maximum observed concentration of ZP4207 (Cmax)
Time frame:5 hours
concentration, descriptive
Pharmacokinetics: time to maximum observed concentration of ZP4207 (tmax)
Time frame:5 hours
time to event, event
Pharmacokinetics: terminal elimination rate constant estimated during the terminal phase of ZP4207 (λz)
Time frame:5 hours
descriptive
Pharmacokinetics: the terminal plasma elimination half-life of ZP4207 (t½),
Time frame:5 hours
concentration, descriptive
Pharmacokinetics: apparent volume of distribution of ZP4207 based on plasma concentration values (Vz), estimated during the terminal Phase (f): (Vz/f)
Time frame:5 hours
concentration, descriptive
Pharmacokinetics: apparent plasma clearance rate of ZP4207(CL) estimated during the terminal Phase (f)
Time frame:5 hours
concentration, descriptive
Pharmacokinetics: mean residence time for plasma ZP4207 (MRT)
Time frame:5 hours
concentration, descriptive
Pharmacodynamics: maximum observed concentration (Cmax)
Time frame:5 hours
concentration, descriptive
Pharmacodynamics: time to maximum observed concentration (tmax)TPG≥70mg/dL
Time frame:5 hours
threshold achievement, event
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 November 5, 2026 snapshot.