Trials / Completed
CompletedNCT04612517
A Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Doses of ZP7570 in Healthy Subjects
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a randomised, double-blind, placebo-controlled, multiple ascending dose trial in healthy subjects, randomised to ZP7570 or placebo within each cohort
Detailed description
Forty subjects are planned to be studied in four cohorts in this multiple ascending dose trial. Ten subjects will be allocated to four dose levels. Intermediate dose levels may be applied. A sentinel dosing approach (sequential dosing) will be applied. The entire observation period comprises 51 days starting with a 96 hours in-house stay after the first dose injection, where discharge is planned for Day 5, followed by one outpatient visit. For the second and the third injection dose a 36 hours in-house stay is planned. After the fourth dose injection there is also a 96 hour in-house stay where discharge is planned for Day 26, followed by five outpatient visits and an End of Trial Visit on Day 51. A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next planned dose level based on the stopping rules specified in the protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZP7570 | Each subject will be randomly allocated to multiple doses of ZP7570 at one of four dose levels in each cohort. |
| DRUG | Placebo | Placebo; corresponding volume |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
- First posted
- 2020-11-03
- Last updated
- 2021-09-02
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04612517. Inclusion in this directory is not an endorsement.