Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT04569994
Eligibility Criteria:
Inclusion Criteria:
Part 1 (healthy subjects):
* Male subject or female subject of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Part 2 and 3 (subjects with type 1 diabetes mellitus):
* Male subject or female subject of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 1 diabetes mellitus 1 year or more prior to the day of screening.
* Glycated haemoglobin (HbA1c) equal to or below 8.5%.
* Fasting C-peptide below 0.30 nmol/L.
* Considered to be generally healthy (except for type 1 diabetes mellitus and sequelae of diabetes which may only be of mild severity) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
Part 1 (healthy subjects) Part 2 and Part 3 (subjects with type 1 diabetes mellitus):
\- Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04569994
Study Brief:
Protocol Section:
NCT04569994