Phase 1
Completed N=32
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Healthy Subjects
Source: ClinicalTrials.gov NCT01544361 ↗
Enrolled (actual)
32
Serious AEs
3.1%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — 4; 2; 4; 3 Participants
Summary
This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
4; 2; 4; 3; 1; 1 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of MEDI7814 |
— | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 years up to and including 49 years at the time of first dose of investigational product
- Healthy by medical history, physical examination, and laboratory studies
- Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive)
- Females must be of non-childbearing potential.
Exclusion criteria
- Any acute illness within 30 days of screening
- Concurrent enrollment in another clinical trial
- The subject has a positive drug/alcohol screen at screening or Day -1
- Pregnancy
- Current cigarette smokers
- History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
- Use of immunosuppressive medications
- Subjects who have an unresolved infection with any Neisseria species
- Subjects who have had their spleen removed for any reason.
Data sourced from ClinicalTrials.gov (NCT01544361). 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. Informational only — not medical advice.