Trials / Completed
CompletedNCT04197349
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Detailed description
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALD1910 | Single Dose IV infusion |
| BIOLOGICAL | Sumatriptan | Single dose subcutaneous injection |
| BIOLOGICAL | ALD1910 | Single dose subcutaneous injection |
Timeline
- Start date
- 2019-09-24
- Primary completion
- 2020-08-19
- Completion
- 2020-08-19
- First posted
- 2019-12-13
- Last updated
- 2020-09-23
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04197349. Inclusion in this directory is not an endorsement.