HealthyPhase 1NCT00822978
Phase 1 Study for Safety of ACHN-490
A Phase 1 study of Healthy, run by Achaogen, Inc. at 1 site in United States.
Trial summary
This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2009
- 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
- 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 noise
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 the the ears
- No family history of hearing loss before the age of 65
- Not taking any medication other than birth control medication
- Smokers or use of tobacco products
- Recent blood donor
- Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-controlled, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in Healthy Volunteers
This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.
- Conditions
- Healthy
- Being tested
- ACHN-490 Injection vs placebo
- Keywords
- healthy, volunteers, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACHN-490 Injection vs placeboDrug
Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe.
| Study group | Role | What they receive |
|---|---|---|
| ACHN-490 Injection | Active comparator | ACHN-490 Injection in escalating doses Receives: Drug: ACHN-490 Injection vs placebo |
| 2 | Placebo comparator | Placebo is normal saline Receives: Drug: ACHN-490 Injection vs placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident and severity of adverse events
Measured: 2 weeks after the last dose for each dose group
Secondary outcomes (2)
Changes from baseline in kidney function, laboratory values, abd vital signs
Measured: single and multi-dose
Pharmacokinetic parameters
Measured: After single and multiple-dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionOct 2009
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carter Brooks, MD, Principal investigator, Jasper Clinic, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822978
- Sponsor's protocol ID
- ACHN-490-001
- Status last verified
- Feb 2012
- First submitted
- 13 Jan 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, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00822978
- Acronym / sponsor ID
- ACHN-490-001
- Conditions
- Healthy
- Keywords
- healthy, volunteers, subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Jan 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.
This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.
Study design
- 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 Injection vs placeboACHN-490 Injection in escalating doses |
| 2 | Placebo comparator | Drug: ACHN-490 Injection vs placeboPlacebo is normal saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 noise
Key exclusion criteria (8 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 the the ears
- No family history of hearing loss before the age of 65
- Not taking any medication 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 Injection vs placeboEscalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe. | Drug | 2, ACHN-490 Injection |
Primary outcome
Incident and severity of adverse events
Time frame: 2 weeks after the last dose for each dose group
2 secondary outcomes
Changes from baseline in kidney function, laboratory values, abd vital signs
Time frame: single and multi-dose
Pharmacokinetic parameters
Time frame: After single and multiple-dose administration
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.
Carter Brooks, MD principal investigator
Jasper Clinic, Michigan
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 of Healthy, run by Achaogen, 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 4 inclusion and 8 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.
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. 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?
Incident and severity of adverse events (time frame: 2 weeks after the last dose for each dose group). 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.