Healthy Volunteers
Conditions
Brief summary
The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.
Detailed description
SAD Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed. SAD Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety, PK and PD will be assessed. SAD Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed. MAD Part: Participants will receive multiple doses of either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
Interventions
DRUGZP9830
SAD: Participants will receive 1 single dose of ZP9830 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. MAD: Participants will receive multiple doses of ZP9830 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort.
DRUGPlacebo
SAD: Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Volume will be matching the active treatment. MAD: Participants will receive multiple doses of placebo given subcutaneously (s.c., under the skin). Volume will be matching the active treatment.
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel (active or placebo), sequential (dose escalation)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants. * 18-45 years of age (inclusive). * Body weight ≥50 kg. * SAD part B only: Fitzpatrick skin type I-III (Caucasian). * C-reactive protein ≤10 mg/L. * Further inclusion criteria apply.
Exclusion criteria
* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the Investigator \[following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ECG\]. * Any disease associated with immune system impairment, including immune mediated diseases and transplantation patients. * Any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites. * History of neurological disorders including neuropathy, as judged by the investigator. * Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable). * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident of Treatment Emergent Adverse Events (TEAEs) | From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41) | Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up |
Countries
Netherlands
Contacts
CONTACTClinical Trial Information desk
STUDY_DIRECTORZealand Pharma A/S
Zealand Pharma A/S
Outcome results
None listed