Phase 3
Completed N=320
A Study to Evaluate the Safety and Tolerability of Raxibacumab in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT00639678 ↗
Enrolled (actual)
320
Serious AEs
0.6%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period — 32; 6; 103; 10 Participants
Summary
To evaluate the safety and tolerability of raxibacumab in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period |
32; 6; 103; 10; 0; 1 | — |
| PRIMARY Number of Participants With Hematological Toxicities of the Indicated Grade |
4; 0; 15; 2; 1; 0 | — |
| PRIMARY Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities |
1; 0; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants With Liver Toxicities of the Indicated Grade |
2; 0; 7; 0; 0; 0 | — |
| PRIMARY Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Electrolyte Toxicities of the Indicated Grade |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Other Chemistry Toxicities of the Indicated Grade |
0; 0; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Thyroid Toxicities of the Indicated Grade |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Urinalysis Toxicities of the Indicated Grade |
9; 0; 31; 3; 3; 0 | — |
| PRIMARY Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities |
3; 0; 8; 0; 4; 0 | — |
| PRIMARY Number of Participants Who Developed an Anti-raxibacumab Antibody Response |
0; 0; 0; 0 | — |
| SECONDARY Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose |
0.048; 928.447; 881.586; 311.669; 199.043; 89.021 | — |
| SECONDARY Mean Raxibacumab Concentration-time Following Two IV Infusion Doses |
0; 1012.564; 973.910; 314.374; 1246.223; 1211.572 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male or female, 18 years of age or older
- Normal laboratory (blood test) results
- Subjects are eligible to enter the study if they are not pregnant or nursing, are sterile or of non-childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study (about 2 months)
Key Exclusion Criteria
- History of significant, acute or chronic diseases (ie, heart, lung, gastrointestinal, liver, kidney, neurological or infectious diseases).
- Prior immunization with anthrax vaccine adsorbed (AVA), prior treatment with investigational anthrax therapies, prior treatment for anthrax exposure, or prior anthrax infection.
- History of Type I hypersensitivity reaction to food or drugs, IV contrast agents, antihistamines, or history of hives.
- A current drug or alcohol addiction.
- Positive for human immunodeficiency virus (HIV-1), Hepatitis B surface antigen, or Hepatitis C antibody.
- Cancer within the last 5 years (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix).
- Participation within 60 days of intiating study or refusal to refrain from participation during the study in any other clinical trials of an investigational compound.
- Previous exposure to raxibacumab.
Data sourced from ClinicalTrials.gov (NCT00639678). 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.