HypoglycemiaPhase 1NCT02367053
Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
A Phase 1 study testing ZP4207 and Glucagon in people with Hypoglycemia, run by Zealand Pharma at 1 site in Germany.
Trial summary
The trial is a randomized, double-blind First in Human trial to evaluate the safety and tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts. 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 and Glucagon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Apr 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
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
- Male subjects which are healthy for part 1; for part 2 male subjects with T1D
- Age between 18 and 50 years, both inclusive.
- Body weight between 70 and 90 kg, both inclusive.
- Subjects must be in good health according to age (medical history, physical examination, vital signs, ECG, lab assessments), as judged by the investigator
- A subject who is surgically sterilized or must be willing to refrain from sexual intercourse during the trial and until one month after completion of the trial or if sexually active, using condom and partner practices contraception during the trial and until one month after completion of the trial.
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- For part 2, in addition:
- Male subjects with T1D for at least one year, as defined by the American Diabetes Association.
- Having been treated with insulin for T1D for at least 1 year.
- Stable disease with HbA1c < 8.5 %.
- Stable insulin treatment during participation in trial and 3 month prior to the screening visit.
Who cannot join
- Known or suspected allergy to trial product(s) or related products.
- Previous participation (randomization) in this trial.
- Receipt of any investigational drug within 3 months prior to screening.
- A history or presence of cancer, diabetes (part 1 only), or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases.
- Clinically significant illness within 4 weeks before screening, as judged by the investigator
- Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies.
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- Positive result of test for HIV antibodies.
- Any clinically significant abnormal hematology,biochemistry or urinalysis screening tests, as judged by the Investigator.
- Clinically significant abnormal ECG at screening as evaluated by Investigator.
- Donation of blood or plasma in the past month, or in excess of 500 ml within 12 weeks prior to screening.
- A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer, 1 glass of wine, or 20 ml of spirits).
- Habitual smoking, i.e., daily smoking or more than 7 cigarettes/week within the last 3 months prior to screening. Subjects have to accept refraining from smoking while at the clinical site.
- Subjects with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the Investigator should not participate in the trial.
- Surgery or trauma with significant blood loss within the last 2 months prior to screening.
- Any condition interfering with trial participation or evaluation or that may be hazardous to the subject.
- For part 2, in addition
- Severe hypoglycemic events within one year prior to screening, as judged by the investigator.
- Significant changes in basal insulin within 3 weeks before screening, as judged by the investigator.
- Clinically relevant diabetic complications (macrovascular disease with symptoms of coronary artery disease or peripheral vascular disease, microvascular disease with symptoms of neuropathy, gastroparesis, retinopathy, nephropathy, or poor blood glucose control with polyuria, polydipsia, or weight loss), as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded Trial of Single Ascending Doses of ZP4207 Administered s.c. or i.m. to HV and a SD of ZP4207 Administered s.c. to Hypoglycemic T1D to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207 as Compared to an Active Comparator
The trial is a randomized, double-blind First in Human trial to evaluate the safety and tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.
Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c. in 4-5 cohorts and i.m. in 3 cohorts.
Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over design in a randomized treatment order.
- Conditions
- Hypoglycemia
- Being tested
- ZP4207, Glucagon
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP4207Drug
GlucagonDrug
| Study group | Role | What they receive |
|---|---|---|
| ZP4207 | Experimental | single dose of ZP4207 in ascending doses (s.c. and i.m.) Receives: Drug: ZP4207 |
| native glucagon | Active comparator | single fixed dose of glucagon Receives: Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of participants with adverse events
Measured: 28 days
Safety and Tolerability: Changes or findings from baseline in clinical safety laboratory assessments
Measured: 28 days
Safety and Tolerability: Changes or findings from baseline in physical examination
Measured: 28 days
Safety and Tolerability: Changes or findings from baseline in vital signs
Measured: 28 days
Safety and Tolerability: Changes or findings from baseline in ECG
Measured: 28 days
Safety and Tolerability: Findings in local tolerability
Measured: 28 days
Secondary outcomes (12)
Pharmacokinetics (PK): Area under the curve (AUC) from time-point 0 until 300min
Measured: 5 hours
Pharmacokinetics: maximum observed concentration of ZP4207 (Cmax)
Measured: 5 hours
Pharmacokinetics: time to maximum observed concentration of ZP4207 (tmax)
Measured: 5 hours
Pharmacokinetics: terminal elimination rate constant estimated during the terminal phase of ZP4207 (λz)
Measured: 5 hours
Pharmacokinetics: the terminal plasma elimination half-life of ZP4207 (t½),
Measured: 5 hours
Pharmacokinetics: apparent volume of distribution of ZP4207 based on plasma concentration values (Vz), estimated during the terminal Phase (f): (Vz/f)
Measured: 5 hours
Pharmacokinetics: apparent plasma clearance rate of ZP4207(CL) estimated during the terminal Phase (f)
Measured: 5 hours
Pharmacokinetics: mean residence time for plasma ZP4207 (MRT)
Measured: 5 hours
Pharmacodynamics (PD): Area under the Plasma glucose curve from time-point 0 until 300 min (AUCgluc 0-300)
Measured: 5 hours
Pharmacodynamics: maximum observed concentration (Cmax)
Measured: 5 hours
Pharmacodynamics: time to maximum observed concentration (tmax)TPG≥70mg/dL
Measured: 5 hours
Pharmacodynamics: Time to plasma glucose equal or above (70 mg/dL)
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Jax, MD/PhD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367053
- Sponsor's protocol ID
- ZP4207-14013
- Status last verified
- Jan 2016
- First submitted
- 3 Feb 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Trial of Single Ascending Doses of ZP4207 Administered s.c. or i.m. to HV and a SD of ZP4207 Administered s.c. to Hypoglycemic T1D to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207 as Compared to an Active Comparator
- ClinicalTrials.gov ID
- NCT02367053
- Acronym / sponsor ID
- ZP4207-14013
- Conditions
- Hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is a randomized, double-blind First in Human trial to evaluate the safety and tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.
Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c. in 4-5 cohorts and i.m. in 3 cohorts.
Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over design in a randomized treatment order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZP4207 | Experimental | Drug: ZP4207single dose of ZP4207 in ascending doses (s.c. and i.m.) |
| native glucagon | Active comparator | Drug: Glucagonsingle fixed dose of glucagon |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
- Male subjects which are healthy for part 1; for part 2 male subjects with T1D
- Age between 18 and 50 years, both inclusive.
- Body weight between 70 and 90 kg, both inclusive.
- Subjects must be in good health according to age (medical history, physical examination, vital signs, ECG, lab assessments), as judged by the investigator
Key exclusion criteria (19 listed)
- Known or suspected allergy to trial product(s) or related products.
- Previous participation (randomization) in this trial.
- Receipt of any investigational drug within 3 months prior to screening.
- A history or presence of cancer, diabetes (part 1 only), or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases.
- Clinically significant illness within 4 weeks before screening, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZP4207 | Drug | ZP4207 |
| Glucagon | Drug | native glucagon |
Primary outcome
Safety and Tolerability: Number of participants with adverse events
Time frame: 28 days
Safety and Tolerability: Changes or findings from baseline in clinical safety laboratory assessments
Time frame: 28 days
Safety and Tolerability: Changes or findings from baseline in physical examination
Time frame: 28 days
Safety and Tolerability: Changes or findings from baseline in vital signs
Time frame: 28 days
Safety and Tolerability: Changes or findings from baseline in ECG
Time frame: 28 days
Safety and Tolerability: Findings in local tolerability
Time frame: 28 days
12 secondary outcomes
Pharmacokinetics (PK): Area under the curve (AUC) from time-point 0 until 300min
Time frame: 5 hours
Pharmacokinetics: maximum observed concentration of ZP4207 (Cmax)
Time frame: 5 hours
Pharmacokinetics: time to maximum observed concentration of ZP4207 (tmax)
Time frame: 5 hours
Pharmacokinetics: terminal elimination rate constant estimated during the terminal phase of ZP4207 (λz)
Time frame: 5 hours
Pharmacokinetics: the terminal plasma elimination half-life of ZP4207 (t½),
Time frame: 5 hours
Pharmacokinetics: apparent volume of distribution of ZP4207 based on plasma concentration values (Vz), estimated during the terminal Phase (f): (Vz/f)
Time frame: 5 hours
Pharmacokinetics: apparent plasma clearance rate of ZP4207(CL) estimated during the terminal Phase (f)
Time frame: 5 hours
Pharmacokinetics: mean residence time for plasma ZP4207 (MRT)
Time frame: 5 hours
Pharmacodynamics (PD): Area under the Plasma glucose curve from time-point 0 until 300 min (AUCgluc 0-300)
Time frame: 5 hours
Pharmacodynamics: maximum observed concentration (Cmax)
Time frame: 5 hours
Pharmacodynamics: time to maximum observed concentration (tmax)TPG≥70mg/dL
Time frame: 5 hours
Pharmacodynamics: Time to plasma glucose equal or above (70 mg/dL)
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jax, MD/PhD principal investigator
Profil GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZP4207 and Glucagon 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 11 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 22 Jan 2016. 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. 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?
Safety and Tolerability: Number of participants with adverse events (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2016.