Clinical trial NCT06682975: A Research Study Looking at the Safety of Single Doses of ZP9830 and How it Works in the Body of Healthy Participants
Official title: A First-in-human, Randomized and Double-blind Within Cohorts, Placebo-controlled, Single Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP9830 Administered to Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Parallel (active or placebo), sequential (dose escalation)
Primary purpose: TREATMENT

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: 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.

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.

Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.

Eligibility criteria: Inclusion Criteria:

Healthy male subject.

18-45 years of age (inclusive).

Body weight ≥50 kg.

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 exclusion criteria apply.

Primary outcomes:
measure: Incident of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From dosing of ZP9830 (Day 1) to follow-up (Day 29)
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
state: CL
Study officials:
affiliation: Zealand Pharma A/S
name: Zealand Pharma A/S
role: STUDY_DIRECTOR
References: