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HypoglycemiaPhase 1NCT02390141

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

A Phase 1 study testing ZP4207 in people with Hypoglycemia, run by Zealand Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypoglycemia
What is being tested?
ZP4207
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteGermany
Study dates
Apr 2015to Aug 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of paracetamol or acetylsalicylic acid for occasional use to treat acute pain.
  • Blood donation or blood loss of more than 500 mL within the last 3 months.
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation.
  • Male who is sexually active and not surgically sterilized who and whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures include surgical sterilisation, hormonal intrauterine devices [coil], oral hormonal contraceptives, each in combination with spermicide-coated condoms), or who is not willing to refrain from sexual intercourse from the first dosing until 1 month after last dosing in the trial.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Randomized, Placebo-controlled, Double-blind Trial of Multiple Ascending Doses of ZP4207 Administered to Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP4207

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
Being tested
ZP4207, Placebo
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZP4207Drug

  • PlaceboDrug

Study groups in NCT02390141
Study groupRoleWhat they receive
ZP4207ExperimentalFive multiple doses of ZP4207 in ascending doses
Receives: Drug: ZP4207
PlaceboPlacebo comparatorFive multiple doses of corresponding placebo in ascending doses
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Number of participants with adverse events

    Measured: 28 days

  2. Number of participants with adverse events

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

    Measured: 28 days

  3. 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)

    Measured: 28 days

  4. 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))

    Measured: 28 days

  5. Number of participants with adverse events

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

    Measured: 28 days

  6. 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

    Measured: 28 days

  7. Number of participants with adverse events

    Immunogenicity (Anti-ZP4207 Antibodies)

    Measured: 28 days

Secondary outcomes (13)

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

    Areas under the plasma concentration curve from 0 until 300min

    Measured: 5h

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

    Areas under the plasma concentration curve from 0 until infinity

    Measured: 5 h

  3. Plasma concentration curve compared between first and last dosing

    Maximum observed ZP4207 concentration

    Measured: 5 h

  4. Plasma concentration curve compared between first and last dosing

    Time to maximum observed ZP4207 concentration

    Measured: 5 h

  5. Plasma concentration curve compared between first and last dosing

    Terminal elimination rate constant of ZP4207

    Measured: 5 h

  6. Plasma concentration curve compared between first and last dosing

    Terminal plasma elimination half-life calculated as t½=ln2/λz

    Measured: 5 h

  7. Plasma concentration curve compared between first and last dosing

    Apparent volume of distribution of ZP4207 based on plasma concentration values, estimated during the terminal phase

    Measured: 5 h

  8. Pharmacokinetic endpoints compared between first and last dosing

    Apparent plasma clearance rate of ZP4207 estimated during the terminal phase

    Measured: 5 h

  9. Pharmacokinetic endpoints compared between first and last dosing

    Mean residence time for plasma ZP4207

    Measured: 5 h

  10. Pharmacodynamic endpoints compared between first and last dosing

    Area under the plasma glucose curve from 0 until 300min

    Measured: 5 h

  11. Pharmacodynamic endpoints compared between first and last dosing

    Maximum observed plasma glucose concentration

    Measured: 5 h

  12. Pharmacodynamic endpoints compared between first and last dosing

    Time to maximum plasma glucose concentration

    Measured: 5 h

  13. Pharmacodynamic endpoints compared between first and last dosing

    Delta (time to increase) of glucose of 2 mmol/

    Measured: 5 h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390141
Sponsor's protocol ID
ZP4207-15007
Status last verified
Nov 2015
First submitted
28 Feb 2015
Last updated
11 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZP4207 in people with Hypoglycemia, run by Zealand Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.

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