A Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

NCT03994549 | Completed Early Phase 1

• 2 other identifiers: ZP7570-181442019-001128-36
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.

Conditions

Healthy

Keywords

Dual GLP-1R/GLP-2 Receptor agonist

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of adverse events (AEs)

  The incidence, type and severity of adverse events (AEs)

  From time zero to 28 days after dosing

Secondary Outcomes (24)

• Pharmacokinetics - Area under the plasma concentration-time curve trough

  From time zero up to day 28

• Pharmacokinetics - Area under the plasma concentration-time curve infinity

  From time zero up to day 28

• Pharmacokinetics - Area under the plasma concentration-time curve last

  From time zero up to day 28

• Pharmacokinetics - Maximum plasma concentration

  From time zero to 28 days after dosing

• Pharmacokinetics - Time to maximum plasma concentration (Tmax)

  From time zero to 28 days after dosing

Study Arms (2)

ZP7570

ACTIVE COMPARATOR

Single subcutaneous injection

Drug: Dual GLP-1/GLP-2 Receptor agonists

Placebo

PLACEBO COMPARATOR

Single subcutaneous injection

Drug: Dual GLP-1/GLP-2 Receptor agonists

Interventions

Dual GLP-1/GLP-2 Receptor agonists DRUG

Eight ascending doses of ZP7570

Also known as: ZP7570

Placebo; ZP7570

Eligibility Criteria

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

You may qualify if:

• Healthy male or female subject aged between 18 and 55 years, both inclusive.
• Body Mass Index (BMI) between 18.5 and 28.0 kg/m\^2, both inclusive
• Body weight of at least 60 kg.
• Heart rate after 5 minutes rest in supine position inside the range of 50-90 beats/min at screening

You may not qualify if:

• Any history of a disorder which in the investigator's opinion might jeopardize subjects safety, evaluation of results or compliance with the protocol.
• History of gallbladder disease or cholecystectomy.
• History of major depressive disorder or a Patient Health Questionnaire (PHQ-9) \> 9 completed at screening, or a history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
• Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening.
• Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, including a QTcF \> 450 ms (males) or QTcF \> 470 ms (females), PR ≥ 220 ms and QRS ≥ 110 ms as evaluated by the investigator.
• History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction or contraindication to the use of Indocyanine Green (e.g. hypersensitivity to iodine).
• Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.
• TSH values outside of normal reference ranges of safety laboratory
• Estimated glomerular filtration rate (eGFR) \< 90 ml/min/1.73 m2, as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
• Known or suspected hypersensitivity to IMP(s) or related products.
• Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
• Symptoms of arterial hypotension
• Women of childbearing potential who are not using a highly effective contraceptive method
• Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 28 days after dosing
• Men with pregnant partner not willing to use male contraception (condom) until 28 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Study Officials

• Ulrike Hövelmann, MD

  Profil Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: June 21, 2019
• Study Start: June 14, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)