ANB019-001
18 evidence topics · 3 sources
Objective
Primary objective in the first-in-human study
Location and study date
Registry dates
| Milestone | Reported date |
|---|---|
| First participant enrollment | “3/04/2017” |
| Last participant enrollment | “26/09/2017” |
| Last data collection | “15/01/2018” |
Study design
Healthy-volunteer trial design
Randomization ratio in the healthy-volunteer cohorts
Allocation concealment
Eligibility criteria
Registered age range
| Criterion | Value |
|---|---|
| Minimum age | “18 Years” |
| Maximum age | “65 Years” |
Treatment
Single ascending doses: studied range
Multiple ascending intravenous doses: studied range and frequency
Study outcomes
Rationale for using adverse event incidence as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets
Safety assessment method specified in the registry
Results
Participant disposition
Poster-reported assessment period
Baseline characteristics
No evidence found.
Efficacy results
Healthy-volunteer pharmacokinetics: half-life and subcutaneous bioavailability
Clinical efficacy in GPP
Not applicable.
Health-related quality of life and patient-reported outcomes
Not applicable.
Safety results
Treatment-emergent adverse events: participants and percentages
| Cohort | ANB019 | Placebo |
|---|---|---|
| Single ascending dose | “29 (81%)” | “11 (92%)” |
| Multiple ascending dose | “16 (89%)” | “3 (50%)” |
Study limitations
Summary
The congress poster reports 72 healthy volunteers, including 48 in the single ascending dose cohorts and 24 in the multiple ascending dose cohorts, with an assessment period of 85 days. These data do not establish clinical efficacy in GPP or longer-term safety during chronic treatment. The registry lists 73 participants overall, whereas the poster reports 72 healthy volunteers; the available evidence in this report does not reconcile that difference.