HealthyPhase 1NCT00360737
Safety Study of 7 Botulinum Antitoxin Serotypes Derived From Horses
A Phase 1 study testing Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) in people with Healthy, run by Emergent BioSolutions at 1 site in United States.
Trial summary
The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin Serotypes derived from horses using various laboratory measurements, clinical examinations and adverse events. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body-mass index of 20 to 30 with minimum body weight of 111 lb (50 kg).
- For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
- Using hormonal contraception (oral or injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
- IUD inserted at least 2 months prior to dosing.
- For female subjects who are postmenopausal less than 2 years an FSH >= 40 mIU/mL must be obtained. IF the FSH is < 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above for acceptable forms of contraception.
- Normal and healthy as determined by medical history, physical examination, ECG, vital signs and test of liver, kidney and hematological functions.
- Written Informed Consent
Who cannot join
- Any known or documented allergies to horses (e.g. rash, wheezing, rhinitis etc. after exposure to horses)
- Any known or documented allergies to horse serum (observation of adverse events after treatment with any kind of products containing horse serum)
- Any severe food allergies, seasonal allergies or hay fever requiring therapy such as treatment with immunosuppressive drugs
- Known acute or chronic asthma requiring treatment with immunosuppressive drugs
- History of hypersensitivity to blood products derived from a human or equine source
- Heavy smokers (>10 cigarettes a day)
Show all 16Show fewer
- Use of nicotine containing products
- Use of any investigational product within the past 30 days
- Pregnancy or lactation
- Positive serological test for HIV, HBV, or HCV
- History of, or suspected substance abuse problem (including alcohol) or failure of alcohol or drug screen at screening or at baseline
- Individuals with a history of allergy to latex or rubber
- Hemoglobin level of < 12 g/dL.
- Significant blood loss or blood donation within 56 days prior to dosing.
- Any plasma donation within 7 days prior to dosing.
- Demonstrated potential for allergic reaction to NP-018 based on positive horse dander (E3) IgE test or positive NP-018 skin sensitivity test prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of a Heptavalent Equine-derived Botulinum Antitoxin (NP-018)
The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin Serotypes derived from horses using various laboratory measurements, clinical examinations and adverse events. In addition, following intravenous (injected into the vein) administration assessing how much 7 Botulinum Antitoxin remains in the body.
Read the detailed description
Clostridial toxins are amongst the most toxic substances known to science (Middlebrook, 1995). In the United States and other countries, human exposure to Clostridium botulinum toxins usually occurs through food poisoning, wound botulism and colonizing infections in neonates. Recent events have heightened concern about the possibility of botulinum toxins being used in a bioterrorist attack. In order to be prepared for a biological attack as well as the usual human exposures, numerous therapeutic products have been or currently are undergoing development to treat or prevent botulism, including the use of human or equine derived antibodies for post-exposure prophylaxis of botulinum toxin exposure (Gelzleichter et al, 1999; Hibbs et al, 1996; Metzger and Lewis, 1979 and Keller and Stiehm, 2000).
Botulinum antitoxins have been in use to treat adult exposure to botulinum toxin for at least 40 years (Cupo et al, 2001). The use of botulinum antitoxins to treat individuals exposed to botulinum toxin is similar to the use of passive immune therapy with immune globulins collected from immunized or convalescing human donors to treat a wide range of bacterial and viral infectious diseases (Chippaux et al, 1998).
NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from plasma obtained from horses that have been immunized with a specific subtype of botulinum toxoid and toxin. Each individual horse is immunized against a single botulinum toxin subtype. Plasma is pooled from horses that have been immunized with the same botulinum toxin subtype. For each antitoxin serotype (A-G), a despeciated product will be produced by pepsin digestion of the IgG monomer in the equine plasma, yielding predominantly F(ab¢)2 fragment. Following the formulation, the seven antitoxin serotypes will be blended into a heptavalent product and filled into single-use vials.
The present clinical study is intended to assess the pharmacokinetics and safety of NP 018 following intravenous administration. The pharmacokinetics of NP 018 will be comparable to other equine derived antitoxin products. NP 018 will be safe to administer to normal healthy volunteers.
- Conditions
- Healthy
- Being tested
- Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)
- Keywords
- Clinical Trials, Investigational Drug, Healthy Volunteers, Botulinum Antitoxin, Phoenix, Arizona
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)Biological
Also called Botulism Antitoxin (BAT)
Biological/Vaccine NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from pooled plasma obtained from horses that have been immunized against one of seven botulinum antitoxins (A-G). .
| Study group | Role | What they receive |
|---|---|---|
| NP-018 - 1 vial | Experimental | Subjects received one vials of NP-018 administered intravenously. Receives: Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) |
| NP-018 - 2 vials | Experimental | Subjects receive two vials of NP-018 administered intravenously. Receives: Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects with adverse events over the course of the study
Number of subjects with AEs and severity of AEs up to Day 28
Measured: From Screening Day 1 to Day 28 or early withdrawal
Subjects with serious adverse events over the course of the study
Number of subjects with SAEs up to Day 28
Measured: From Screening Day 1 to Day 28 or early withdrawal
Secondary outcomes (8)
PK analysis for all 7 botulinum antitoxins: AUC0-t
AUC0-t (area under the serum concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Day Screening 2, Day 0 -30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-inf
AUC0-inf (area under the serum concentration versus time curve from time 0 to infinity) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-t/AUC0-inf
AUC0-t/AUC0-inf (ratio of AUC0-t to AUC0-inf) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Cmax
Cmax (maximum measured serum concentration over the time span specified) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Tmax
Tmax (time of the maximum measured serum concentration) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: t½
t½ (apparent first-order terminal elimination half-life) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Cl
Cl (clearance of NP-018) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Vd
Vd (initial volume of distribution) will be calculated for all 7 botulinum antitoxins for each subject after NP-018 administration
Measured: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2006
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 subjects will receive 1 or 2 vials of NP-018 intravenously. 20 subjects will be randomized into each arm of the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Mark J. Allison, M.D., Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360737
- Sponsor's protocol ID
- AA24424 BT-001
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2006
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Middlebrook JL. Protection strategies against botulinum toxin. Adv Exp Med Biol. 1995;383:93-8. doi: 10.1007/978-1-4615-1891-4_11. No abstract available.
PubMed 8644518Gelzleichter TR, Myers MA, Menton RG, Niemuth NA, Matthews MC, Langford MJ. Protection against botulinum toxins provided by passive immunization with botulinum human immune globulin: evaluation using an inhalation model. J Appl Toxicol. 1999 Dec;19 Suppl 1:S35-8. doi: 10.1002/(sici)1099-1263(199912)19:1+3.0.co;2-9.
PubMed 10594898Hibbs RG, Weber JT, Corwin A, Allos BM, Abd el Rehim MS, Sharkawy SE, Sarn JE, McKee KT Jr. Experience with the use of an investigational F(ab')2 heptavalent botulism immune globulin of equine origin during an outbreak of type E botulism in Egypt. Clin Infect Dis. 1996 Aug;23(2):337-40. doi: 10.1093/clinids/23.2.337.
PubMed 8842274Metzger JF, Lewis GE Jr. Human-derived immune globulins for the treatment of botulism. Rev Infect Dis. 1979 Jul-Aug;1(4):689-92. doi: 10.1093/clinids/1.4.689.
PubMed 399376Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.
PubMed 11023960Cupo P, de Azevedo-Marques MM, Sarti W, Hering SE. Proposal of abolition of the skin sensitivity test before equine rabies immune globulin application. Rev Inst Med Trop Sao Paulo. 2001 Jan-Feb;43(1):51-3. doi: 10.1590/s0036-46652001000100010.
PubMed 11246284Chippaux JP, Lang J, Eddine SA, Fagot P, Rage V, Peyrieux JC, Le Mener V. Clinical safety of a polyvalent F(ab')2 equine antivenom in 223 African snake envenomations: a field trial in Cameroon. VAO (Venin Afrique de l'Ouest) Investigators. Trans R Soc Trop Med Hyg. 1998 Nov-Dec;92(6):657-62. doi: 10.1016/s0035-9203(98)90802-1.
PubMed 10326114
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Heptavalent Equine-derived Botulinum Antitoxin (NP-018)
- ClinicalTrials.gov ID
- NCT00360737
- Acronym / sponsor ID
- AA24424 BT-001
- Conditions
- Healthy
- Keywords
- Clinical Trials, Investigational Drug, Healthy Volunteers, Botulinum Antitoxin, Phoenix, Arizona
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the safety of the 7 Botulinum Antitoxin Serotypes derived from horses using various laboratory measurements, clinical examinations and adverse events. In addition, following intravenous (injected into the vein) administration assessing how much 7 Botulinum Antitoxin remains in the body.
Detailed description
Clostridial toxins are amongst the most toxic substances known to science (Middlebrook, 1995). In the United States and other countries, human exposure to Clostridium botulinum toxins usually occurs through food poisoning, wound botulism and colonizing infections in neonates. Recent events have heightened concern about the possibility of botulinum toxins being used in a bioterrorist attack. In order to be prepared for a biological attack as well as the usual human exposures, numerous therapeutic products have been or currently are undergoing development to treat or prevent botulism, including the use of human or equine derived antibodies for post-exposure prophylaxis of botulinum toxin exposure (Gelzleichter et al, 1999; Hibbs et al, 1996; Metzger and Lewis, 1979 and Keller and Stiehm, 2000).
Botulinum antitoxins have been in use to treat adult exposure to botulinum toxin for at least 40 years (Cupo et al, 2001). The use of botulinum antitoxins to treat individuals exposed to botulinum toxin is similar to the use of passive immune therapy with immune globulins collected from immunized or convalescing human donors to treat a wide range of bacterial and viral infectious diseases (Chippaux et al, 1998).
NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from plasma obtained from horses that have been immunized with a specific subtype of botulinum toxoid and toxin. Each individual horse is immunized against a single botulinum toxin subtype. Plasma is pooled from horses that have been immunized with the same botulinum toxin subtype. For each antitoxin serotype (A-G), a despeciated product will be produced by pepsin digestion of the IgG monomer in the equine plasma, yielding predominantly F(ab¢)2 fragment. Following the formulation, the seven antitoxin serotypes will be blended into a heptavalent product and filled into single-use vials.
The present clinical study is intended to assess the pharmacokinetics and safety of NP 018 following intravenous administration. The pharmacokinetics of NP 018 will be comparable to other equine derived antitoxin products. NP 018 will be safe to administer to normal healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 40 subjects will receive 1 or 2 vials of NP-018 intravenously. 20 subjects will be randomized into each arm of the study.
| Arm | Type | Receives |
|---|---|---|
| NP-018 - 1 vial | Experimental | Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)Subjects received one vials of NP-018 administered intravenously. |
| NP-018 - 2 vials | Experimental | Biological: Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)Subjects receive two vials of NP-018 administered intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body-mass index of 20 to 30 with minimum body weight of 111 lb (50 kg).
- For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
- Using hormonal contraception (oral or injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
- IUD inserted at least 2 months prior to dosing.
- For female subjects who are postmenopausal less than 2 years an FSH >= 40 mIU/mL must be obtained. IF the FSH is < 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above for acceptable forms of contraception.
Key exclusion criteria (16 listed)
- Any known or documented allergies to horses (e.g. rash, wheezing, rhinitis etc. after exposure to horses)
- Any known or documented allergies to horse serum (observation of adverse events after treatment with any kind of products containing horse serum)
- Any severe food allergies, seasonal allergies or hay fever requiring therapy such as treatment with immunosuppressive drugs
- Known acute or chronic asthma requiring treatment with immunosuppressive drugs
- History of hypersensitivity to blood products derived from a human or equine source
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE)Also: Botulism Antitoxin (BAT)Biological/Vaccine NP-018 (heptavalent equine-derived botulinum antitoxin) is prepared from pooled plasma obtained from horses that have been immunized against one of seven botulinum antitoxins (A-G). . | Biological | NP-018 - 1 vial, NP-018 - 2 vials |
Primary outcome
Subjects with adverse events over the course of the study
Time frame: From Screening Day 1 to Day 28 or early withdrawal
Number of subjects with AEs and severity of AEs up to Day 28
Subjects with serious adverse events over the course of the study
Time frame: From Screening Day 1 to Day 28 or early withdrawal
Number of subjects with SAEs up to Day 28
8 secondary outcomes
PK analysis for all 7 botulinum antitoxins: AUC0-t
Time frame: Day Screening 2, Day 0 -30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-inf
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: AUC0-t/AUC0-inf
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Cmax
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Tmax
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: t½
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Cl
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
PK analysis for all 7 botulinum antitoxins: Vd
Time frame: Screening Day 2, Day 0- 30 minutes, 4 hours, 8 hours, Day 1 [24 hours], Day 3, Day 7, Day 14, Day 21, Day 28 or early withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 8644518Middlebrook JL. Protection strategies against botulinum toxin. Adv Exp Med Biol. 1995;383:93-8. doi: 10.1007/978-1-4615-1891-4_11. No abstract available.
- Background: PubMed 10594898Gelzleichter TR, Myers MA, Menton RG, Niemuth NA, Matthews MC, Langford MJ. Protection against botulinum toxins provided by passive immunization with botulinum human immune globulin: evaluation using an inhalation model. J Appl Toxicol. 1999 Dec;19 Suppl 1:S35-8. doi: 10.1002/(sici)1099-1263(199912)19:1+3.0.co;2-9.
- Background: PubMed 8842274Hibbs RG, Weber JT, Corwin A, Allos BM, Abd el Rehim MS, Sharkawy SE, Sarn JE, McKee KT Jr. Experience with the use of an investigational F(ab')2 heptavalent botulism immune globulin of equine origin during an outbreak of type E botulism in Egypt. Clin Infect Dis. 1996 Aug;23(2):337-40. doi: 10.1093/clinids/23.2.337.
- Background: PubMed 399376Metzger JF, Lewis GE Jr. Human-derived immune globulins for the treatment of botulism. Rev Infect Dis. 1979 Jul-Aug;1(4):689-92. doi: 10.1093/clinids/1.4.689.
- Background: PubMed 11023960Keller MA, Stiehm ER. Passive immunity in prevention and treatment of infectious diseases. Clin Microbiol Rev. 2000 Oct;13(4):602-14. doi: 10.1128/CMR.13.4.602.
- Background: PubMed 11246284Cupo P, de Azevedo-Marques MM, Sarti W, Hering SE. Proposal of abolition of the skin sensitivity test before equine rabies immune globulin application. Rev Inst Med Trop Sao Paulo. 2001 Jan-Feb;43(1):51-3. doi: 10.1590/s0036-46652001000100010.
- Background: PubMed 10326114Chippaux JP, Lang J, Eddine SA, Fagot P, Rage V, Peyrieux JC, Le Mener V. Clinical safety of a polyvalent F(ab')2 equine antivenom in 223 African snake envenomations: a field trial in Cameroon. VAO (Venin Afrique de l'Ouest) Investigators. Trans R Soc Trop Med Hyg. 1998 Nov-Dec;92(6):657-62. doi: 10.1016/s0035-9203(98)90802-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J. Allison, M.D. principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum Antitoxin Heptavalent (A B C D E F G) - (EQUINE) in people with Healthy, run by Emergent BioSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with adverse events over the course of the study (time frame: From Screening Day 1 to Day 28 or early withdrawal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360737, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.