Trials / Completed
CompletedNCT02452372
A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)
A Phase 1, Single-ascending Dose, Multiple-ascending Dose, and Multi-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN AS1 in Patients With Acute Intermittent Porphyria (AIP)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | givosiran (ALN-AS1) | Single or multiple doses of ALN-AS1 by subcutaneous (sc) injection |
| DRUG | Sterile Normal Saline (0.9% NaCl) | calculated volume to match active comparator |
Timeline
- Start date
- 2015-05-06
- Primary completion
- 2017-09-06
- Completion
- 2017-09-06
- First posted
- 2015-05-22
- Last updated
- 2018-06-14
Locations
6 sites across 3 countries: United States, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02452372. Inclusion in this directory is not an endorsement.