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

Zealand Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Overweight

Treatments: Drug: ZP8396; Drug: Placebo (ZP8396)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05096598

ZP8396-21037

U1111-1267-1489 (Other Identifier)

2021-001712-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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
• Further inclusion criteria apply

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
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

ZP8396

Experimental group

Description:

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

Treatment:

Drug: ZP8396

Placebo (ZP8396)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (ZP8396)