Chronic PainPhase 1NCT03220633
Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects
A Phase 1 study testing ATB-346 in people with Chronic Pain, run by Antibe Therapeutics Inc. at 1 site in Canada.
Trial summary
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ATB-346
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2014
- 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
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Healthy male or female subjects aged between 18 and 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2
- Non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least six months before Day 1 of this study
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, these must be without any clinical significance
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- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, electrocardiogram [ECG], and urinalysis)
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
- A female volunteer must meet one of the following criteria:
- If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
- Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- Intrauterine device (with or without hormones)
- Condom with spermicide
- If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses)
- A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must meet the following criterion:
- Participant is inapt to procreate, defined as surgically sterile (i.e. has undergone a vasectomy, it must be at least 6 months since the surgery)
- Participant agrees to use of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse.
- Condom with spermicide.
Who cannot join
- Females who are pregnant or breastfeeding
- Seated pulse rate less than 50 Beats per Minute (bpm) or more than 100 bpm at screening
- Seated blood pressure below 100/60 mmHg or higher than 140/90 mmHg at screening
- History of significant hypersensitivity to naproxen, other non-steroidal anti-inflammatory agents, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or know to potentiate or predispose to undesired effects
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
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- Suicidal tendency, history of/or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically significant ECG abnormalities
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before Day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort) in the previous 28 days before Day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive urine screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAg) or anti-Hepatitis C Virus (HCV) tests
- Females who are pregnant according to a positive serum pregnancy test
- Volunteers who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
- Volunteers who donated 50 mL or more of blood in the previous 28 days before Day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc) in the previous 56 days before Day 1 of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.
Read the detailed description
Single ascending doses of ATB-346 given to multiple cohorts followed by multiple ascending doses of ATB-346 given to multiple cohorts in order to assess its safety, tolerability, and pharmacokinetics. A single dose cohort was also conducted to assess the effect of food on the drug's characteristics.
- Conditions
- Chronic Pain
- Being tested
- ATB-346, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB-346Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ATB-346 | Experimental | Subjects given single dose (SAD cohorts) or multiple doses over a 14 day period (MAD cohorts) of ATB-346. Receives: Drug: ATB-346 |
| Placebo | Placebo comparator | Subjects given single dose (SAD cohorts) or multiple doses over a 14 day period (MAD cohorts) of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Serum chemistry and hematology laboratory measures
Measured: Within one week following single dose administration or within one week following the final dose after two weeks of treatment regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antibe Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220633
- Sponsor's protocol ID
- ATB-346-101
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2015
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects
- ClinicalTrials.gov ID
- NCT03220633
- Acronym / sponsor ID
- ATB-346-101
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Antibe Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jul 2017 (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.
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.
Detailed description
Single ascending doses of ATB-346 given to multiple cohorts followed by multiple ascending doses of ATB-346 given to multiple cohorts in order to assess its safety, tolerability, and pharmacokinetics. A single dose cohort was also conducted to assess the effect of food on the drug's characteristics.
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 |
|---|---|---|
| ATB-346 | Experimental | Drug: ATB-346Subjects given single dose (SAD cohorts) or multiple doses over a 14 day period (MAD cohorts) of ATB-346. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects given single dose (SAD cohorts) or multiple doses over a 14 day period (MAD cohorts) of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Healthy male or female subjects aged between 18 and 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) greater than or equal to 18.50 kg/m2 and below 30.00 kg/m2
- Non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least six months before Day 1 of this study
Key exclusion criteria (18 listed)
- Females who are pregnant or breastfeeding
- Seated pulse rate less than 50 Beats per Minute (bpm) or more than 100 bpm at screening
- Seated blood pressure below 100/60 mmHg or higher than 140/90 mmHg at screening
- History of significant hypersensitivity to naproxen, other non-steroidal anti-inflammatory agents, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or know to potentiate or predispose to undesired effects
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 |
|---|---|---|
| ATB-346 | Drug | ATB-346 |
| Placebo | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Within one week following single dose administration or within one week following the final dose after two weeks of treatment regimen
Serum chemistry and hematology laboratory measures
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 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ATB-346 in people with Chronic Pain, run by Antibe Therapeutics Inc. at 1 site in Canada.
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 20 inclusion and 18 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 Jul 2017. 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 Canada. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Within one week following single dose administration or within one week following the final dose after two weeks of treatment regimen). 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 18 Jul 2017.