A Research Study Looking at the Safety of Single Doses of ZP9830 and How it Works in the Body of Healthy Participants

Zealand Pharma

Status and phase: Enrolling; Phase 1

Conditions: Autoimmune Diseases

Treatments: Drug: Placebo; Drug: ZP9830

Study type: Interventional

Funder types: Industry

Identifiers

NCT06682975

U1111-1305-8892 (Other Identifier)

2023-509929-51 (EudraCT Number)

ZP9830-23005

2023-509929-51-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

ZP9830

Experimental group

Description:

Up to 10 single cohorts planned: Part A, 3 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830. Part B, 6 cohorts of each 10 participants with 8 participants receiving s.c. active treatment of ZP9830. Part C, 1 cohort of 8 participants with 6 participants receiving i.v. active treatment of ZP9830

Treatment:

Drug: ZP9830

Placebo

Placebo Comparator group

Description:

In each of the 10 single dose cohorts, 2 subjects will receive placebo

Treatment:

Drug: Placebo