Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator

What Was Tested

The trial (phase 1) is built around Glucagon.

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.

It had two arms (groups): ZP4207 (experimental) and native glucagon (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 111 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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.

The full record lists 10 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-12 with completion listed for 2015-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 111 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.