Healthy VolunteersPhase 1NCT03388216
Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
A Phase 1 study testing Drug: INM004 Dose 1, Drug: INM004 Dose 2 and Drug: INM004- Repeated dose in people with Healthy Volunteers, run by Inmunova S.A. at 1 site in Argentina.
Trial summary
This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Drug: INM004 Dose 1, Drug: INM004 Dose 2 and Drug: INM004- Repeated dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Dec 2017to 28 Sep 2018
- 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: between 19 and 27.
- Healthy subject, as determined by clinical exam, medical history and laboratory tests (chemistry, hematology and urine, pregnancy test if applicable) performed during the screening visit.
- Chest x-ray and electrocardiogram within normal ranges.
- -.Willing to participate and sign the informed consent.
- Women of child-bearing potential using at least two barrier birth control methods.
- Sexually active men using medically accepted birth control methods, such as condom with spermicide.
Who cannot join
- Known hypersensitivity to equine serum.
- Hypersensitivity to any of the components of the pharmaceutical preparation.
- History of severe allergic reactions to any type of antigen.
- History of mental illness.
- Participation in another clinical research study within 90 days6 months prior to the start of this study
- History of alcohol or drug abuse.
Show all 19Show fewer
- History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, hematological, neurological disease.
- Having received contrast substances for radiological studies of any kind in the two weeks prior to the start of the study.
- Receiving or having received any prescription drug within the two weeks prior to the start of the study, including oral contraceptives in women of child-bearing potential.
- Having received more than three doses of any over-the-counter medication during the week prior to the start of the study or any medication within two days prior to the hospitalization
- Having given blood within a period of under 2 months prior to the start of the study
- Documented infection with HIV, hepatitis B and/or hepatitis C.
- Pregnancy
- History of asthma, allergy, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
- History of vaccination within the month prior to the start of the study.
- Infectious disease requiring hospitalization within the month prior to the inclusion in the study.
- Having received a transfusion of blood products within three months prior to the inclusion in the study
- Having received any medication within 14 days prior to the inclusion in the study.
- Family relation or work relation to the personnel of the research group.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aire
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of the Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.
Read the detailed description
This is a study that will be conducted at a single site in Argentina to characterize the Pharmacokinetics (PK) profile, safety and tolerability of anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in 14 healthy subjects. This is a dose escalation study. Subjects will receive a single dose of an infusion of the biological product or placebo in Stage I where 2 cohorts will be assessed with 2 different doses of INM004. Subjects will receive a repeated dose (3 doses total, every 24 hs) of an infusion of the biological product or placebo in Stage II. The total duration of study participation is 4 weeks for each subject. Subjects will complete a follow-up visit at Day 30 after the dosing. Study duration is expected to last 6 months. The investigational product intent to use is for the prevention of the development of Hemolytic Uremic Syndrome (HUS) associated to Shigatoxin producing Escherichia coli (STEC).
- Conditions
- Healthy Volunteers
- Being tested
- Drug: INM004 Dose 1, Drug: INM004 Dose 2, Drug: INM004- Repeated dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: INM004 Dose 1Biological
Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -
Drug: INM004 Dose 2Biological
Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo)
Drug: INM004- Repeated doseBiological
Stage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo).
PlaceboOther
A placebo infusion will be administered at the same infusion rate as the Drug arm
| Study group | Role | What they receive |
|---|---|---|
| Stage I - Drug: INM004 Dose 1 | Experimental | Not described Receives: Biological: Drug: INM004 Dose 1 |
| Stage I - Placebo Dose 1 | Placebo comparator | Not described Receives: Other: Placebo |
| Stage I- Drug: INM004 Dose 2 | Experimental | Not described Receives: Biological: Drug: INM004 Dose 2 |
| Stage I- Placebo Dose 2 | Placebo comparator | Not described Receives: Other: Placebo |
| Stage II- Drug: INM004 Repeated Dose | Experimental | Not described Receives: Biological: Drug: INM004- Repeated dose |
| Stage II- Placebo Repeated Dose | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 4 weeks
Maximum Plasma Concentration [Cmax]
Measured: 4 weeks
Area Under the Curve [AUC]
Measured: 4 weeks
Elimination half-life (t½)
Measured: 4 weeks
Time of Maximum concentration observed (Tmax)
Measured: 4 weeks
Secondary outcomes (1)
Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start16 Dec 2017
- Primary completion27 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunova S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires
- Responsible party
- Sponsor
- Investigators
- Santiago Sanguineti, Ph.D, Study director, Inmunova S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388216
- Sponsor's protocol ID
- CT-INM004-01
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of the Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03388216
- Acronym / sponsor ID
- CT-INM004-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Inmunova S.A.University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 2 Jan 2018 (actual)
- 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.
This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.
Detailed description
This is a study that will be conducted at a single site in Argentina to characterize the Pharmacokinetics (PK) profile, safety and tolerability of anti-Shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) in 14 healthy subjects. This is a dose escalation study. Subjects will receive a single dose of an infusion of the biological product or placebo in Stage I where 2 cohorts will be assessed with 2 different doses of INM004. Subjects will receive a repeated dose (3 doses total, every 24 hs) of an infusion of the biological product or placebo in Stage II. The total duration of study participation is 4 weeks for each subject. Subjects will complete a follow-up visit at Day 30 after the dosing. Study duration is expected to last 6 months. The investigational product intent to use is for the prevention of the development of Hemolytic Uremic Syndrome (HUS) associated to Shigatoxin producing Escherichia coli (STEC).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage I - Drug: INM004 Dose 1 | Experimental | Biological: Drug: INM004 Dose 1 |
| Stage I - Placebo Dose 1 | Placebo comparator | Other: Placebo |
| Stage I- Drug: INM004 Dose 2 | Experimental | Biological: Drug: INM004 Dose 2 |
| Stage I- Placebo Dose 2 | Placebo comparator | Other: Placebo |
| Stage II- Drug: INM004 Repeated Dose | Experimental | Biological: Drug: INM004- Repeated dose |
| Stage II- Placebo Repeated Dose | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index: between 19 and 27.
- Healthy subject, as determined by clinical exam, medical history and laboratory tests (chemistry, hematology and urine, pregnancy test if applicable) performed during the screening visit.
- Chest x-ray and electrocardiogram within normal ranges.
- -.Willing to participate and sign the informed consent.
- Women of child-bearing potential using at least two barrier birth control methods.
Key exclusion criteria (19 listed)
- Known hypersensitivity to equine serum.
- Hypersensitivity to any of the components of the pharmaceutical preparation.
- History of severe allergic reactions to any type of antigen.
- History of mental illness.
- Participation in another clinical research study within 90 days6 months prior to the start of this study
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 |
|---|---|---|
| Drug: INM004 Dose 1Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) - | Biological | Stage I - Drug: INM004 Dose 1 |
| Drug: INM004 Dose 2Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) | Biological | Stage I- Drug: INM004 Dose 2 |
| Drug: INM004- Repeated doseStage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo). | Biological | Stage II- Drug: INM004 Repeated Dose |
| PlaceboA placebo infusion will be administered at the same infusion rate as the Drug arm | Other | Stage I - Placebo Dose 1, Stage I- Placebo Dose 2, Stage II- Placebo Repeated Dose |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 4 weeks
Maximum Plasma Concentration [Cmax]
Time frame: 4 weeks
Area Under the Curve [AUC]
Time frame: 4 weeks
Elimination half-life (t½)
Time frame: 4 weeks
Time of Maximum concentration observed (Tmax)
Time frame: 4 weeks
1 secondary outcome
Number of participants with treatment-related hypersensitivity events as assessed by CTCAE v4.0
Time frame: 4 weeks
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 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Santiago Sanguineti, Ph.D study director
Inmunova S.A.
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 Drug: INM004 Dose 1, Drug: INM004 Dose 2 and Drug: INM004- Repeated dose in people with Healthy Volunteers, run by Inmunova S.A. at 1 site in Argentina.
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 6 inclusion and 19 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 27 Feb 2019. 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 Argentina. 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. Some participants in this study may receive a placebo. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.