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

NCT05096598 | Completed Phase 1

• 3 other identifiers: ZP8396-210372021-001712-28U1111-1267-1489
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAEs)

  From dosing (Day 1) to end of trial (Day 50)

Secondary Outcomes (28)

• Pharmacokinetics (PK) of ZP8396 (AUCτ)

  Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

• Pharmacokinetics (PK) of ZP8396 (AUCinf)

  Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

• Pharmacokinetics (PK) of ZP8396 (AUClast)

  Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

• Pharmacokinetics (PK) of ZP8396 (Cmax)

  Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

• Pharmacokinetics (PK) of ZP8396 (tmax)

  Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Study Arms (2)

ZP8396

EXPERIMENTAL

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

Drug: ZP8396

Placebo (ZP8396)

PLACEBO COMPARATOR

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

Drug: Placebo (ZP8396)

Interventions

ZP8396 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.

ZP8396

Placebo (ZP8396) 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).

Placebo (ZP8396)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zealand Pharma A/S

  Zealand Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: October 19, 2021
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)