Healthy VolunteersPhase 1NCT01034774
Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
A Phase 1 study testing ACHN-490 Injection in people with Healthy Volunteers, run by Achaogen, Inc..
Trial summary
Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ACHN-490 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or Women
- Within normal weight limits
- In good health with normal routine laboratory results
- Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noises
Who cannot join
- No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
- No problems with hearing or balance
- No previous injury or surgery to the ears
- No family history of hearing loss before the age of 65
- Not taking any medications other than birth control medication
- Smokers or use of tobacco products
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- Recent blood donors
- No excessive alcohol intake or illegal substances
- No allergy to aminoglycosides (a type of antibiotic)
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) ACHN-490 in Healthy Subjects
Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- ACHN-490 Injection, Placebo (normal saline)
- Keywords
- Human volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHN-490 InjectionDrug
ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment.
Placebo (normal saline)Drug
Also called Normal Saline, NS
Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
| Study group | Role | What they receive |
|---|---|---|
| ACHN-490 Injection | Active comparator | ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg. Receives: Drug: ACHN-490 Injection |
| Placebo is Normal Saline | Placebo comparator | Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given. Receives: Drug: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days
Measured: Throughout the study
Secondary outcomes (2)
Lung penetration as estimated from ACHN-490 measured in ELF
Measured: 1 Day
Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing
Measured: Through 24 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJul 2010
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy A Havrilla, MS, RN, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034774
- Sponsor's protocol ID
- ACHN-490-003
- Status last verified
- Feb 2012
- First submitted
- 16 Dec 2009
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) ACHN-490 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01034774
- Acronym / sponsor ID
- ACHN-490-003
- Conditions
- Healthy Volunteers
- Keywords
- Human volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Dec 2009 (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.
Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACHN-490 Injection | Active comparator | Drug: ACHN-490 InjectionACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg. |
| Placebo is Normal Saline | Placebo comparator | Drug: Placebo (normal saline)Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or Women
- Within normal weight limits
- In good health with normal routine laboratory results
- Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noises
Key exclusion criteria (9 listed)
- No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
- No problems with hearing or balance
- No previous injury or surgery to the ears
- No family history of hearing loss before the age of 65
- Not taking any medications other than birth control medication
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 |
|---|---|---|
| ACHN-490 InjectionACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment. | Drug | ACHN-490 Injection |
| Placebo (normal saline)Also: Normal Saline, NSPlacebo is given at the same volume as ACHN-490 Injection to maintain the blind. | Drug | Placebo is Normal Saline |
Primary outcome
Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days
Time frame: Throughout the study
2 secondary outcomes
Lung penetration as estimated from ACHN-490 measured in ELF
Time frame: 1 Day
Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing
Time frame: Through 24 hours after the last dose
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 2012.
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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.
Nancy A Havrilla, MS, RN study director
Achaogen, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACHN-490 Injection in people with Healthy Volunteers, run by Achaogen, Inc..
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 4 inclusion and 9 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 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days (time frame: Throughout the study). 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 2012.