Healthy VolunteersPhase 1NCT04097405
Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
A Phase 1 study testing D-0120 in people with Healthy Volunteers, run by InventisBio Co., Ltd at 1 site in United States.
Trial summary
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- D-0120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 18 Nov 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be medically documented as healthy at physical examination
- Moderate smokers or non-smokers
- Subjects must be between the ages of 18 and 60
- Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
- Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
- Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
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- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
- Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
- Subjects must have a complete blood count and platelet count within the normal range
- Subjects must have a normal urinalysis
- Subjects must have a normal estimated glomerular filtration rate
- Subjects must have a normal ECG
- Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
Who cannot join
- Subjects with any history or clinical manifestations of disorders
- Subjects who have any history or suspicion of kidney stones
- Subjects who are HIV, Hep B or Hep C positive
- History of significant allergic reactions to any drug
- Clinically significant ECG abnormalities
- History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
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- Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
- Positive urine drug screen, alcohol breath at screening
- Subjects had undergone major surgery within 3 months
- Women who are pregnant or breastfeeding
- History of significant alcohol abuse
- Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
- Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
- Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
- Donation of plasma within 7 days prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- D-0120, Placebo oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120Drug
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
Placebo oral tabletDrug
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| D-0120 Dose Ascending Cohorts 1-4 | Active comparator | D-0120 dose daily for up to 7 days. Receives: Drug: D-0120 |
| Placebo Dose Ascending Cohorts 1-4 | Placebo comparator | Placebo dose daily for up to 7 days Receives: Drug: Placebo oral tablet |
| D-0120/Uric Acid Lowering Agent Cohort 6 | Experimental | D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy Receives: Drug: D-0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with treatment related adverse events as assessed
Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs
Measured: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)
Secondary outcomes (3)
Time to observed Cmax (Tmax)for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax
Measured: Timeframe: Day 1-Day7
Area under the plasma concentration-time curve (AUC) for D-0120
Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC
Measured: Day 1-Day 7
Maximum Observed Plasma Concentration (Cmax) of D-0120
Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax
Measured: Day 1-Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start18 Sep 2019
- Primary completion30 Mar 2020
- Study completion18 Nov 2020
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.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097405
- Sponsor's protocol ID
- IBIO-203
- Status last verified
- Feb 2021
- First submitted
- 18 Sep 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04097405
- Acronym / sponsor ID
- IBIO-203
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 20 Sep 2019 (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.
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D-0120 Dose Ascending Cohorts 1-4 | Active comparator | Drug: D-0120D-0120 dose daily for up to 7 days. |
| Placebo Dose Ascending Cohorts 1-4 | Placebo comparator | Drug: Placebo oral tabletPlacebo dose daily for up to 7 days |
| D-0120/Uric Acid Lowering Agent Cohort 6 | Experimental | Drug: D-0120D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subjects must be medically documented as healthy at physical examination
- Moderate smokers or non-smokers
- Subjects must be between the ages of 18 and 60
- Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
- Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
Key exclusion criteria (15 listed)
- Subjects with any history or clinical manifestations of disorders
- Subjects who have any history or suspicion of kidney stones
- Subjects who are HIV, Hep B or Hep C positive
- History of significant allergic reactions to any drug
- Clinically significant ECG abnormalities
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 |
|---|---|---|
| D-0120Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo | Drug | D-0120 Dose Ascending Cohorts 1-4, D-0120/Uric Acid Lowering Agent Cohort 6 |
| Placebo oral tabletRandomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo | Drug | Placebo Dose Ascending Cohorts 1-4 |
Primary outcome
The number of subjects with treatment related adverse events as assessed
Time frame: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)
Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs
3 secondary outcomes
Time to observed Cmax (Tmax)for D-0120
Time frame: Timeframe: Day 1-Day7
Area under the plasma concentration-time curve (AUC) for D-0120
Time frame: Day 1-Day 7
Maximum Observed Plasma Concentration (Cmax) of D-0120
Time frame: Day 1-Day 7
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 10 Feb 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 D-0120 in people with Healthy Volunteers, run by InventisBio 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 14 inclusion and 15 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 10 Feb 2021. 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?
The number of subjects with treatment related adverse events as assessed (time frame: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)). 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 10 Feb 2021.