Healthy VolunteersPhase 1NCT02858973
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
A Phase 1 study testing Q203 in people with Healthy Volunteers, run by Qurient Co., Ltd. at 1 site in United States.
Trial summary
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Q203
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 8 May 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
Read the detailed description
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.
Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.
Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.
- Conditions
- Healthy Volunteers
- Being tested
- Q203, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q203Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Q203 | Experimental | Q203 tablets Receives: Drug: Q203 |
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring
Measured: 16 days post dose
Secondary outcomes (3)
Pharmacokinetic analysis: Area under the curve
Measured: 16 days post dose
Pharmacokinetic analysis: Maximum observed plasma drug concentration
Measured: 16 days post dose
Pharmacokinetic analysis: Time of maximum observed concentration
Measured: 16 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completion8 May 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858973
- Sponsor's protocol ID
- Q203-TB-PI-US002
- Status last verified
- Apr 2018
- First submitted
- 1 Aug 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02858973
- Acronym / sponsor ID
- Q203-TB-PI-US002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- May 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 8 Aug 2016 (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 randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
Detailed description
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.
Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.
Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q203 | Experimental | Drug: Q203Q203 tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
Key exclusion criteria (3 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the 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 |
|---|---|---|
| Q203 | Drug | Q203 |
| Placebo | Drug | Placebo |
Primary outcome
Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring
Time frame: 16 days post dose
3 secondary outcomes
Pharmacokinetic analysis: Area under the curve
Time frame: 16 days post dose
Pharmacokinetic analysis: Maximum observed plasma drug concentration
Time frame: 16 days post dose
Pharmacokinetic analysis: Time of maximum observed concentration
Time frame: 16 days post 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 14 May 2018.
- Individual participant dataSharing planned: No
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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 Q203 in people with Healthy Volunteers, run by Qurient Co., Ltd. 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 2 inclusion and 3 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 14 May 2018. 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?
Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring (time frame: 16 days post dose). 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 14 May 2018.