HealthyPhase 1NCT02486770
Study of Single Doses of IV Aerucin in Healthy Adults
A Phase 1 study testing Aerucin 2.0mg/kg, Aerucin 8.0mg/kg and Aerucin 20.0 mg/kg in people with Healthy, run by Aridis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aerucin 2.0mg/kg, Aerucin 8.0mg/kg and Aerucin 20.0 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has completed the written informed consent process
- Is male or female
- Is age ≥18 years and ≤50 years
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- Agrees to avoid elective surgery for the duration of the study
- For female subjects: agrees to have avoided pregnancy from 14 days prior to Study Day 0 through the duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include: a sterile sexual partner; sexual abstinence (not engaging in any sexual intercourse); hormonal contraceptives (oral, injection, transdermal patch, or implant); vaginal ring; intrauterine device (IUD); or condom.
- Has general good health, confirmed by medical history and physical examination
- Has body mass index (BMI) between 18 and 30 (weight/height) -
Who cannot join
- Oral temperature ≥37.5°C
- Abnormal CBC laboratory values (per local laboratory parameters) from blood collected at screening (>5% above ULN or >5% below LLN)
- Abnormally elevated laboratory values (per local laboratory parameters) from blood collected at screening for ALT, AST, total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine (Cr), (>10% above ULN)
- Abnormal urinalysis that, in the opinion of the investigator, is clinically significant
- Positive screening urine test for illicit drugs (opiates, cocaine, amphetamines)
- Has received an immunoglobulin product in the 120 days prior to Study Day 0
Show all 21Show fewer
- History or evidence of autoimmune disease
- History or evidence of any past, present, or future possible immunodeficiency state, including laboratory evidence of HIV 1 infection.
- History or evidence of chronic hepatitis
- History of evidence of Pseudomonas infection
- Received a systemic antibiotic with 14 days prior to Study Day 0
- Participation in any other investigational study during the study period
- Received immunoglobulin or blood products within 90 days prior to Study Day 0
- Received any investigational drug therapy or investigational drug within 60 days prior to Study Day 0
- Received immunosuppressive medications other than inhaled or topical immunosuppressants within 45 days prior to Study Day 0
- Inability to discontinue daily medications during the study other than: oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin, antihistamines inhaled corticosteroids, inhaled beta agonists, inhaled anticholinergics
- All female subjects: currently pregnant or lactating/nursing; positive screening urine pregnancy test; or positive urine pregnancy test on the day of any study dosing
- History or evidence of allergic disease or reaction that, in the opinion of the investigator, may compromise the safety of the subject
- History or evidence of any other acute or chronic disease that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject
- Medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol
- Any other reason at discretion of the investigator -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single-center (U.S.), Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of Single Doses of Intravenous AerucinTM in Healthy Adult Subjects
This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages.
Read the detailed description
This Phase I trial will be conducted as an open label trial in 15 healthy adults. All subjects will receive a specific intravenous dose of Aerucin. There are three study groups, each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin . Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of Aerucin . The dose levels of Aerucin are selected for this study based on animal studies showing protection in an animal model and absence of adverse effects in toxicological studies. Groups will be enrolled sequentially.
- Conditions
- Healthy
- Being tested
- Aerucin 2.0mg/kg, Aerucin 8.0mg/kg, Aerucin 20.0 mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerucin 2.0mg/kgBiological
IV Aerucin 2.0 mg/kg over 1 hour
Aerucin 8.0mg/kgBiological
IV Aerucin 8.0 mg/kg over 1 hour
Aerucin 20.0 mg/kgBiological
IV Aerucin 20 mg/kg over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Aerucin 2.0mg/kg Receives: Biological: Aerucin 2.0mg/kg |
| Group 2 | Experimental | Aerucin 8.0mg/kg Receives: Biological: Aerucin 8.0mg/kg |
| Group 3 | Experimental | Aerucin 20.0mg/kg Receives: Biological: Aerucin 20.0 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number and % of subjects experiencing adverse events following dosing
Measured: 28 and 84 days following dosing
Serious Adverse Events
Number and % of subjects experiencing Serious Adverse Events following dosing
Measured: 24 and 84 days following dosing
Solicited Adverse Events
Number and % of subjects experiencing Solicited Adverse Events following dosing
Measured: 7 days following dosing
Secondary outcomes (6)
CMax -Observed maximum plasma concentration
Pharmacokinetics Characteristics
Measured: 84 days following dosing
TMax-Time to reach maximum plasma concentration
Pharmacokinetics Characteristics
Measured: 84 days following dosing
AUC0-last Area under the the concentration time curve
Pharmacokinetics Characteristics
Measured: 84 days following dosing
AUC0-∞ Area under the concentration time curve from zero to infinite time
Pharmacokinetics Characteristics
Measured: 84 days following dosing
Terminal phase elimination rate
Pharmacokinetics Characteristics
Measured: 84 days following dosing
Terminal elimination half-life
Pharmacokinetics Characteristics
Measured: 84 days following dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aridis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed Al-Ibrahim, MD, Principal investigator, SNBL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486770
- Sponsor's protocol ID
- ARC-11-01
- Status last verified
- Dec 2015
- First submitted
- 8 Apr 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-center (U.S.), Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of Single Doses of Intravenous AerucinTM in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02486770
- Acronym / sponsor ID
- ARC-11-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aridis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Jul 2015 (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.
This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages.
Detailed description
This Phase I trial will be conducted as an open label trial in 15 healthy adults. All subjects will receive a specific intravenous dose of Aerucin. There are three study groups, each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin . Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of Aerucin . The dose levels of Aerucin are selected for this study based on animal studies showing protection in an animal model and absence of adverse effects in toxicological studies. Groups will be enrolled sequentially.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Aerucin 2.0mg/kgAerucin 2.0mg/kg |
| Group 2 | Experimental | Biological: Aerucin 8.0mg/kgAerucin 8.0mg/kg |
| Group 3 | Experimental | Biological: Aerucin 20.0 mg/kgAerucin 20.0mg/kg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Has completed the written informed consent process
- Is male or female
- Is age ≥18 years and ≤50 years
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- Agrees to avoid elective surgery for the duration of the study
Key exclusion criteria (21 listed)
- Oral temperature ≥37.5°C
- Abnormal CBC laboratory values (per local laboratory parameters) from blood collected at screening (>5% above ULN or >5% below LLN)
- Abnormally elevated laboratory values (per local laboratory parameters) from blood collected at screening for ALT, AST, total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine (Cr), (>10% above ULN)
- Abnormal urinalysis that, in the opinion of the investigator, is clinically significant
- Positive screening urine test for illicit drugs (opiates, cocaine, amphetamines)
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 |
|---|---|---|
| Aerucin 2.0mg/kgIV Aerucin 2.0 mg/kg over 1 hour | Biological | Group 1 |
| Aerucin 8.0mg/kgIV Aerucin 8.0 mg/kg over 1 hour | Biological | Group 2 |
| Aerucin 20.0 mg/kgIV Aerucin 20 mg/kg over 1 hour | Biological | Group 3 |
Primary outcome
Adverse Events
Time frame: 28 and 84 days following dosing
Number and % of subjects experiencing adverse events following dosing
Serious Adverse Events
Time frame: 24 and 84 days following dosing
Number and % of subjects experiencing Serious Adverse Events following dosing
Solicited Adverse Events
Time frame: 7 days following dosing
Number and % of subjects experiencing Solicited Adverse Events following dosing
6 secondary outcomes
CMax -Observed maximum plasma concentration
Time frame: 84 days following dosing
TMax-Time to reach maximum plasma concentration
Time frame: 84 days following dosing
AUC0-last Area under the the concentration time curve
Time frame: 84 days following dosing
AUC0-∞ Area under the concentration time curve from zero to infinite time
Time frame: 84 days following dosing
Terminal phase elimination rate
Time frame: 84 days following dosing
Terminal elimination half-life
Time frame: 84 days following dosing
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 30 Dec 2015.
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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.
Mohammed Al-Ibrahim, MD principal investigator
SNBL
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 Aerucin 2.0mg/kg, Aerucin 8.0mg/kg and Aerucin 20.0 mg/kg in people with Healthy, run by Aridis Pharmaceuticals, Inc. 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 8 inclusion and 21 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 30 Dec 2015. 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?
Adverse Events (time frame: 28 and 84 days following dosing). The study lists 3 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 30 Dec 2015.