Phase 1
N=38
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
Hereditary Angioedema (HAE)
Bottom Line
View on ClinicalTrials.gov: NCT02093923 ↗Enrolled (actual)
38
Serious AEs
2.7%
Results posted
Aug 2016
Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- DX-2930 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
3895.0; 7890.0; 27460.0; 45322.2 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
17.930; 18.020; 18.172; 17.700 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve (AUC) |
64100.0; 135425.0; 451800.0; 762777.8 | — |
| SECONDARY Apparent Clearance (CL/F) |
0.5720; 0.8110; 1.0036; 0.5514 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) |
11.553; 16.125; 17.436; 11.696 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) |
14.225; 14.625; 13.802; 14.967 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age at the time of screening
- Documented diagnosis of HAE (Type I or II)
- Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months reported by the participant
- Willing and able to read, understand, and sign an informed consent form
- Females of childbearing potential must agree to be abstinent or else use acceptable forms of contraception throughout study
- Males with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception throughout study
Exclusion Criteria
- Exposure to an investigational drug or device within 90 days prior to study
- History of exposure within the past 5 years to a monoclonal antibody or recombinant protein bearing an Fc domain
- Concomitant diagnosis of another form of chronic angioedema
- Use of long-term prophylaxis for HAE within 90 days prior to study
- Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study; any use of C1-INH within 7 days prior to study
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to study
- Exposure to androgens within 90 days prior to study
- Presence of an indwelling catheter
- Diagnosis of HIV
- Active liver disease or liver function test abnormalities
- History of substance abuse or dependence
- Pregnancy or breastfeeding
- Any condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results
Data sourced from ClinicalTrials.gov (NCT02093923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.