Safety IssuesPhase 1NCT05004571
Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
A Phase 1 study testing EQU-001 in people with Safety Issues, run by Equilibre Biopharmaceuticals B.V. at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- EQU-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 4 Sep 2021
- 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
- Age 18 to 65 years of age
- Weight 60 kg to 90 kg
- Willing and able to
- communicate in English or Spanish
- provide written informed consent to take part in the study
- be available for all visits and able and willing to comply with all study procedural requirements
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- In general good health in the opinion of the investigator as defined by:
- The absence of clinically significant illness or surgery within 4 weeks of dosing. Participants vomiting within 24 hours before the first study drug administration will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator or designee.
- The absence of clinically significant neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease including uncontrolled diabetes.
- Agree not to participate in other concurrent interventional and/or drug trials
- Agree not to use nicotine containing products
- Agree not to eat grapefruit, drink grapefruit juice or take St. John's wort for 5 days prior to study drug dosing and throughout the study.
- If you or your heterosexual partner is pre-menopausal, you must agree to use an effective method of contraception and to continue use of an effective method for the duration of study participation and 2 weeks after. For this study, a clinical history of amenorrhea for ≥1 year without a separate identifiable cause and a medical history consistent with menopause meets criteria for post-menopausal. Acceptable methods are:
- condom use together with an additional barrier method plus spermicide, hormonal methods, or an IUD
- sterilization of participant or partner
- heterosexual abstinence
Who cannot join
- Pregnant or lactating
- History of hypersensitivity to the EQU-001 API
- History of EQU-001 API use within the previous 2 weeks
- History of ocular conditions that interfere with pupillometry including inability to focus on an object 3 meters in front of them, current eye disorder under the care of an ophthalmologist, or pupil not readily distinguishable from the iris
- History of excessive caffeine use (>8 cups of coffee or caffeine-containing energy drinks per day)
- History of smoking or vaping within the past 3 months
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- History of substance abuse within 6 months (with the exception of medically indicated marijuana), including alcohol
- Use of concomitant prescription medications within 5 days of the study drug dose
- Use of an investigational drug or device or participation in an investigational study within 30 days prior to enrollment
- Donation of blood within the previous 4 weeks
- Has any of the following laboratory abnormalities at screening or baseline:
- Breathalyzer result ≥ 0.1
- Positive COVID test
- Positive urine drug screen
- Positive urine cotinine screen
- Total bilirubin or higher ≥ 1.5 x the site laboratory ULN
- ALT or ALT ≥ 2 x the site laboratory ULN
- HbA1c ≥ 6.5%
- Positive hCG (female pre-menopausal participants)
- Received a COVID-19 vaccine within 7 days of the baseline visit
- Any reason which, in the opinion of the PI, would prevent the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Hialeah, Florida, 33104
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blinded Single and Multiple Ascending Dose (SAD and MAD) Study of the Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.
Read the detailed description
EQU-001 is a Phase 1 randomized, placebo-controlled, double-blind SAD/MAD study to evaluate safety, tolerability, PK, and high-fat food effects on EQU-001. Eight healthy adult participants will be enrolled in each of up to 5 cohorts in both the SAD and MAD portions of the study (10 mg, 20 mg, 40 mg, 80 mg, and 120 mg). The participants will be randomized 3:1, drug to placebo. The MAD dosing is for 14 days, to include a period of time where the study drug will be at steady-state. Eight participants from the SAD study (the 40 mg dose cohort or the MTD dose cohort, whichever dose is lower) will also complete a fed portion of the study.
This study of EQU-001 will provide baseline safety, tolerability, PK, and food effect data in healthy individuals and aims to identify drug-specific DLTs and an MTD. The PK component will characterize the PK of EQU-001 to inform dosing and may help to correlate exposures with any DLTs or other treatment-related AEs. The food effect component will characterize the effect of a high-fat meal on EQU-001 kinetics and exposure.
- Conditions
- Safety Issues
- Being tested
- EQU-001, Placebo
- Keywords
- Healthy, Adult, Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQU-001Drug
EQU-001 in 10 and 20 mg capsules
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched placebo control 10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to placebo subjects in the SAD portion of the study.
10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to placebo subjects in the SAD portion of the study. Receives: Drug: Placebo |
| Study drug EQU-001 | Experimental | 10 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to active-treatment subjects in the SAD portion of the study.
10 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to active treatment subjects in the SAD portion of the study. Receives: Drug: EQU-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs Grade 2 or higher
As defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, November 2017
Measured: Up to 19 days
Change in pupil size from low light under high-light conditions between baseline and day 1 for part 1 (SAD) and day 14 for part 2 (MAD)
Measured: day 1 SAD; day 14 MAD
Secondary outcomes (4)
Number of participants in each MAD cohort who discontinue the study drug because of study drug effects
Measured: Up to 14 days
EQU-001 drug concentration in blood
Measured: From pre-dose to 120 hours post dose in SAD and from pre-dose to 120 hours post the first and 14th doses in the MAD
Differences in EQU-001 drug concentrations in blood and in the parameters below under fasted as compared with fed conditions
Measured: From pre-dose to 120 hours post dose
Incidence of DLTs
Measured: up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start6 Jul 2021
- Primary completion4 Sep 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Sequential
- Model description
- 3:1 treatment to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equilibre Biopharmaceuticals B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Melsaether, MD, Study director, Equilibre Biopharmaceuticals B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004571
- Sponsor's protocol ID
- EQU-101
- Status last verified
- Jan 2023
- First submitted
- 5 Aug 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blinded Single and Multiple Ascending Dose (SAD and MAD) Study of the Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05004571
- Acronym / sponsor ID
- EQU-101
- Conditions
- Safety Issues
- Keywords
- Healthy, Adult, Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Equilibre Biopharmaceuticals B.V.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 13 Aug 2021 (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 is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.
Detailed description
EQU-001 is a Phase 1 randomized, placebo-controlled, double-blind SAD/MAD study to evaluate safety, tolerability, PK, and high-fat food effects on EQU-001. Eight healthy adult participants will be enrolled in each of up to 5 cohorts in both the SAD and MAD portions of the study (10 mg, 20 mg, 40 mg, 80 mg, and 120 mg). The participants will be randomized 3:1, drug to placebo. The MAD dosing is for 14 days, to include a period of time where the study drug will be at steady-state. Eight participants from the SAD study (the 40 mg dose cohort or the MTD dose cohort, whichever dose is lower) will also complete a fed portion of the study.
This study of EQU-001 will provide baseline safety, tolerability, PK, and food effect data in healthy individuals and aims to identify drug-specific DLTs and an MTD. The PK component will characterize the PK of EQU-001 to inform dosing and may help to correlate exposures with any DLTs or other treatment-related AEs. The food effect component will characterize the effect of a high-fat meal on EQU-001 kinetics and exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3:1 treatment to placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo control 10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to placebo subjects in the SAD portion of the study. 10 mg capsules or 20 mg capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to placebo subjects in the SAD portion of the study. |
| Study drug EQU-001 | Experimental | Drug: EQU-00110 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once orally to active-treatment subjects in the SAD portion of the study. 10 mg capsules or 20 mg EQU-001 capsules totaling 20 mg, 40 mg, 80 mg, or 120 mg will be given once daily for 14 days orally to active treatment subjects in the SAD portion of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18 to 65 years of age
- Weight 60 kg to 90 kg
- Willing and able to
- In general good health in the opinion of the investigator as defined by:
- Agree not to participate in other concurrent interventional and/or drug trials
Key exclusion criteria (21 listed)
- Pregnant or lactating
- History of hypersensitivity to the EQU-001 API
- History of EQU-001 API use within the previous 2 weeks
- History of ocular conditions that interfere with pupillometry including inability to focus on an object 3 meters in front of them, current eye disorder under the care of an ophthalmologist, or pupil not readily distinguishable from the iris
- History of excessive caffeine use (>8 cups of coffee or caffeine-containing energy drinks per day)
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 |
|---|---|---|
| EQU-001EQU-001 in 10 and 20 mg capsules | Drug | Study drug EQU-001 |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
AEs Grade 2 or higher
Time frame: Up to 19 days
As defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, November 2017
Change in pupil size from low light under high-light conditions between baseline and day 1 for part 1 (SAD) and day 14 for part 2 (MAD)
Time frame: day 1 SAD; day 14 MAD
4 secondary outcomes
Number of participants in each MAD cohort who discontinue the study drug because of study drug effects
Time frame: Up to 14 days
EQU-001 drug concentration in blood
Time frame: From pre-dose to 120 hours post dose in SAD and from pre-dose to 120 hours post the first and 14th doses in the MAD
Differences in EQU-001 drug concentrations in blood and in the parameters below under fasted as compared with fed conditions
Time frame: From pre-dose to 120 hours post dose
Incidence of DLTs
Time frame: up to 19 days
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 1 Feb 2023.
- 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.
Amy Melsaether, MD study director
Equilibre Biopharmaceuticals B.V.
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 EQU-001 in people with Safety Issues, run by Equilibre Biopharmaceuticals B.V. 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 16 inclusion and 21 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 1 Feb 2023. 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?
AEs Grade 2 or higher (time frame: Up to 19 days). The study lists 2 primary outcomes in all. 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 1 Feb 2023.