A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

NCT ID: NCT05096598

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2023-01-12

Brief Summary

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).

Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).

Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.

Conditions

Overweight; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ZP8396

Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment.

Group Type: EXPERIMENTAL

ZP8396

Intervention Type: DRUG

Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.

Placebo (ZP8396)

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

Group Type: PLACEBO_COMPARATOR

Placebo (ZP8396)

Intervention Type: DRUG

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).

Interventions

ZP8396

Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort.

Intervention Type: DRUG

Placebo (ZP8396)

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subject
• Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
• Body weight of at least 70.0 kg
• Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent

Exclusion Criteria

• History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
• Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
• Symptoms of arterial hypotension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zealand Pharma A/S

Role: STUDY_DIRECTOR

Zealand Pharma A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2021-001712-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1267-1489

Identifier Type: OTHER

Identifier Source: secondary_id

ZP8396-21037

Identifier Type: -

Identifier Source: org_study_id