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

NCT04612517 | Completed Early Phase 1

• 2 other identifiers: ZP7570-181452019-001129-29
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability - Incidence of treatment emergent adverse events as assessed by type and severity

  The incidence, type and severity of treatment emergent adverse events

  From time 0 to 51 days after first dosing (29 days after fourth dosing) ]

Secondary Outcomes (49)

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

  From time 0 to 51 days after first dosing (29 days after fourth dosing)

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

  From time 0 to 51 days after first dosing (29 days after fourth dosing)

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

  From time 0 to 51 days after first dosing (29 days after fourth dosing)

• Pharmacokinetics - Maximum plasma concentration - Cmax

  From time 0 to 51 days after first dosing (29 days after fourth dosing)

• Pharmacokinetics - Time to maximum plasma concentration - Tmax

  From time 0 to 51 days after first dosing (29 days after fourth dosing)

Study Arms (2)

ZP7570

EXPERIMENTAL

Four ascending doses of ZP7570

Drug: ZP7570

Placebo

PLACEBO COMPARATOR

Corresponding volume of placebo

Drug: Placebo

Interventions

ZP7570 DRUG

Each subject will be randomly allocated to multiple doses of ZP7570 at one of four dose levels in each cohort.

Also known as: Dual GLP-1R/GLP-2R agonist

ZP7570

Placebo DRUG

Placebo; corresponding volume

Placebo

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject.
• Healthy male or female subject (only women not of childbearing potential) aged between 18 and 55 years, both inclusive.
• Body Mass Index (BMI) between 18.5 and 28.0 kg/m2, both inclusive
• A 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 pancreatitis
• 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.
• Family history of multiple endocrinological neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
• 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.
• History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction .
• 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

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Study Officials

• Ulrike Hövelmann

  Profil Institut für Stoffwechselforschung GmbH

  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: October 20, 2020
• First Posted: November 3, 2020
• Study Start: October 26, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

DE (1)