Healthy VolunteersPhase 1NCT03542435
Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023
A Phase 1 study testing SXC-2023 in people with Healthy Volunteers, run by Promentis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SXC-2023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 10 Sep 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant screening results.
- For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:
- Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose
- Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Subject is mentally or legally incapacitated
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Females with a positive pregnancy test or is lactating.
- Positive urine cotinine at screening.
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- Positive urine drug or alcohol results at screening
- Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)
- Donation of blood or significant blood loss within 56 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Participation in another clinical study within 30 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 When Administered Orally to Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
- Conditions
- Healthy Volunteers
- Being tested
- SXC-2023, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SXC-2023Drug
Oral capsule
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SXC-2023 | Experimental | Dose Escalation Receives: Drug: SXC-2023 |
| Placebo | Placebo comparator | Dose Escalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse events
Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses
Measured: 18 days
Secondary outcomes (3)
Pharmacokinetic Assessments: Cmax
Peak plasma concentration
Measured: Up to 96 hr post dose
Pharmacokinetic Assessments: Tmax
Time to peak plasma concentration
Measured: Up to 96 hr post dose
Pharmacokinetic Assessments: AUC
Area under the plasma concentration-time curve
Measured: Up to 96 hr post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start26 Apr 2018
- Primary completion8 Aug 2018
- Study completion10 Sep 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promentis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tricia Cotter, Study director, Promentis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542435
- Sponsor's protocol ID
- PRO-104
- Status last verified
- Oct 2018
- First submitted
- 18 May 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 When Administered Orally to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03542435
- Acronym / sponsor ID
- PRO-104
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Promentis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 31 May 2018 (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, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SXC-2023 | Experimental | Drug: SXC-2023Dose Escalation |
| Placebo | Placebo comparator | Drug: PlaceboDose Escalation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.
- Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant screening results.
- For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:
Key exclusion criteria (13 listed)
- Subject is mentally or legally incapacitated
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Females with a positive pregnancy test or is lactating.
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 |
|---|---|---|
| SXC-2023Oral capsule | Drug | SXC-2023 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Treatment related adverse events
Time frame: 18 days
Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses
3 secondary outcomes
Pharmacokinetic Assessments: Cmax
Time frame: Up to 96 hr post dose
Pharmacokinetic Assessments: Tmax
Time frame: Up to 96 hr post dose
Pharmacokinetic Assessments: AUC
Time frame: Up to 96 hr 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 16 Oct 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.
Tricia Cotter study director
Promentis Pharmaceuticals, Inc.
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 SXC-2023 in people with Healthy Volunteers, run by Promentis Pharmaceuticals, 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 8 inclusion and 13 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 16 Oct 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?
Treatment related adverse events (time frame: 18 days). 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 16 Oct 2018.