Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration
Trial end date:
SummaryThe purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of dasiglucagon following SC administration compared to IV administration. Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.
Accepts Healthy Volunteers?Accepts Healthy Volunteers
- Informed consent obtained before any trial-related activities (trial-related
activities are any procedures that would not have been performed during normal
management of the subject).
- Healthy female or male subjects aged between 18 and 45 years, both inclusive.
- Body weight between 60 and 90 kg, both inclusive.
- Subjects in good health according to age (medical history, physical examination, vital
signs, and laboratory assessments), as judged by the investigator.
- Systolic Blood Pressure (SBP) ≥90 mmHg, ≤140 mmHg and Diastolic Blood Pressure (DBP)
≤90 mmHg measured after at least 5 min rest in supine position.
- A pulse rate of ≥50 and ≤90 b/min measured after at least 5 min rest in supine
- 12-lead ECG with QTcF < 450 ms, PR < 220 ms and QRS < 110 ms.
- A female subject must meet one of the following criteria:
- Participant is of childbearing potential and agrees to use one of the accepted
contraceptive regimens throughout the entire duration of the trial from screening
until the last follow-up visit. An acceptable method of contraception includes
one of the following:
- Total heterosexual sexual abstinence can be used as a method of
contraception if this is the participant's preferred lifestyle and the
method is established. Periodic sexual abstinence is not an acceptable
method of contraception
Single method (use only one method):
- intrauterine device (IUD),
- hormone rod inserted under the skin,
- male partner's sterilization
- Hormone contraception A) estrogen and / or progesterone oral contraceptives, B)
transdermal patch, C) vaginal ring, D) injection in combination with one of the
following: a) vaginal cap with spermicide, b) vaginal sponge (only for women who have
never given birth), c) condom, d) female condom
- Participant is of non-childbearing potential, if she is either surgically sterilized
(ie, by tubal ligation or removal of ovaries), has undergone complete hysterectomy, or
is in a menopausal state (i.e., at least one year without menses).
- A male subject who is sexually active and has a female partner who is of
childbearing potential, must use a condom throughout the entire duration of the
trial from screening and until the last follow-up visit.
Condoms MUST be combined with one of the following methods:
- hormone rod inserted under the skin,
- vaginal cap with spermicide,
- vaginal sponge (only for women who have never given birth),
- hormone contraception A) estrogen and / or progesterone oral contraceptives, B)
transdermal patch, C) vaginal ring or D) injection
- Total heterosexual sexual abstinence can be used as a method of contraception if
this is the participant's preferred lifestyle and the method is established.
Periodic sexual abstinence is not an acceptable method of contraception.
- Previous participation in any trial with dasiglucagon. Participation defined as
enrolled into trial.
- Known or suspected hypersensitivity to trial product(s) or related products.
- History of severe hypersensitivity to medicines or foods or history of severe
medicinal/food induced anaphylactic reaction.
- Receipt of any investigational product within 3 months prior to screening.
- Females who are pregnant according to a positive pregnancy test, are actively
attempting to get pregnant, or are lactating.
- Any history or presence of cancer, except adequately treated (as judged by
investigator) basal or squamous cell skin cancer or cervical carcinoma in situ.
- A history or presence of any clinically significant respiratory, metabolic, renal,
hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal,
neurological or psychiatric diseases, or other major diseases at the discretion of the
- Known cardiovascular disease, arthrosclerosis, angina pectoris, or a history of
myocardial infarction or coronary arterial bypass graft/percutaneous coronary
- Clinically significant illness (eg, systemic infection) within 4 weeks before
screening, as judged by the investigator.
- Any significant pre-existing medical condition as well as pre-planned procedures or
- Positive results for Hepatitis B antigens, Hepatitis C antibodies and/or human
immunodeficiency virus (HIV) 1 antigen or HIV1/2 antibodies, at screening.
- Any clinically significant abnormal hematology, biochemistry, or urinalysis screening
tests, as judged by the investigator.
- Any of the following abnormal laboratory parameters at screening:
- alanine aminotransferase (ALT) > upper limit of normal [ULN] + 10%, aspartate
aminotransferase (AST) > ULN + 10%,
- Bilirubin > ULN + 20%
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR
<90 ml/min/1.73 m2 as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
- Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine
position at screening, as evaluated by the investigator.
- Donation of blood or blood loss of more than 500 mL within 12 weeks prior to
- The use of any non-prescribed systemic medication, except routine vitamins and
occasional use of acetylsalicylic acid and paracetamol within 14 days prior to
- A positive result in the alcohol and/or urine drug screen at the screening visit.
- A history of alcoholism or drug abuse as judged by the investigator
- Smokers (defined as a subject who has been smoking within the last 6 month).
- Subjects with mental incapacity or language barriers that 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.