Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207

NCT02390141 | Completed Phase 1

• 1 other identifier: ZP4207-15007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety, tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of ZP4207 or placebo in a 3:1 treatment allocation at trial site.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events

  Number of participants with adverse events

  28 days

• Number of participants with adverse events

  Changes or findings from baseline (normal ranges) in clinical safety laboratory assessments (including haematology, biochemistry, coagulation and urinalysis).

  28 days

• Number of participants with adverse events

  Changes or findings from baseline in physical examination including Head, ears, eyes, nose, throat (HEENT), incl. thyroid gland * Heart, lung, chest * Abdomen * Skin and mucosae * Musculoskeletal system * Nervous system * Lymph node * Other findings)

  28 days

• Number of participants with adverse events

  Changes or findings from baseline in vital signs (including systolic and diastolic blood pressure (mmHG) und heart rate (beats per minute), body temperature (°C), respiratory frequency (RF/min))

  28 days

• Number of participants with adverse events

  Changes or findings from baseline in ECG Parameter (Heart rate, PQ, QRS, QT, QTcB)

  28 days

• Number of participants with adverse events

  Findings in local tolerability by means of the following assessments: * spontaneous pain * pain on palpation * itching * redness * oedema * induration/infiltration * other

  28 days

• Number of participants with adverse events

  Immunogenicity (Anti-ZP4207 Antibodies)

  28 days

Secondary Outcomes (13)

• Areas under the plasma concentration curve compared between first and last dosing

  5h

• Areas under the plasma concentration curve compared between first and last dosing

  5 h

• Plasma concentration curve compared between first and last dosing

  5 h

• Plasma concentration curve compared between first and last dosing

  5 h

• Plasma concentration curve compared between first and last dosing

  5 h

Study Arms (2)

ZP4207

EXPERIMENTAL

Five multiple doses of ZP4207 in ascending doses

Drug: ZP4207

Placebo

PLACEBO COMPARATOR

Five multiple doses of corresponding placebo in ascending doses

Drug: Placebo

Interventions

ZP4207 DRUG

ZP4207

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• 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 performed during normal management of the subject).
• Caucasian
• Healthy male subject.
• Age between 18 and 50 years, both inclusive.
• Body weight between 70 and 90 kg (both inclusive)
• Fasting plasma glucose concentration \<= 100 mg/dL.
• Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.

You may not qualify if:

• Known or suspected hypersensitivity to IMP or related products.
• Previous participation in this trial. Participation is defined as randomized.
• Previous treatment with ZP4207.
• Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
• Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological, haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness as judged by the Investigator.
• Any serious systemic infectious disease during four weeks prior to first dosing of the study drug, as judged by the Investigator.
• Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator.
• Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and for diastolic greater than 90 mmHg or symptoms and a heart rate at rest outside the range of 50-90 beats per minute (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial).
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
• Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer, one glass of wine of 120 mL, or 20 mL spirits).
• A positive result in the alcohol and/or urine drug screen at the screening visit.
• Smoker (defined as a subject who is smoking more than 7 cigarettes or the equivalent per week) within the last month prior to screening and who is not able or willing to refrain from smoking and use of nicotine substitute products one day before first dosing and during the treatment period.
• Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ulrike Hövelmann, MD

  Profil GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

DE (1)