Ulcerative ColitisPhase 1NCT04458805
Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers
A Phase 1 study testing NX-13 250 mg in people with Ulcerative Colitis, run by Landos Biopharma Inc. at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- NX-13 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jul 2020to 21 Oct 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers will be included in Part A or Part B of the study if they satisfy all the following criteria:
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
- Adult males and females, 18 to 64 years of age (inclusive) at screening;
- Body mass index (BMI) ≥ 19.0 and ≤ 31.0 kg/m2, with a body weight ≥ 60.0 and ≤ 85.0 kg at screening;
- Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 1 month prior to first study drug administration;
- Medically healthy without clinically significant abnormalities at screening and pre-dose on Day 1, including:
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- Physical examination without any clinically relevant findings;
- Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position;
- Heart rate (HR) in the range of 50 to 100 bpm after 5 minutes rest in supine position;
- Body temperature, between 35.0°C and 37.5°C;
- No clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the investigator;
- Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at screening and Day-1) consistent with normal cardiac conduction and function, including:
- Normal sinus rhythm with HR between 50 and 100 bpm, inclusive;
- QTcF between 350 to 450 msec for male subjects and 350 to 470 msec for female subjects, inclusive;
- QRS duration of < 120 msec;
- PR interval of ≤ 210 msec;
- Electrocardiogram morphology consistent with healthy cardiac ventricular conduction and normal rhythm, and with measurement of the QT interval;
- No family history of short or long QT syndrome;
- No history of risk factors for torsade de pointes or the diagnosis;
- Female participants must: a. Be of nonchildbearing potential ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b. If of childbearing potential, must have a negative pregnancy test at screening (blood test) and before the first study drug administration (Day -1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (Appendix 4) from signing the consent form until at least 30 days after the last dose of study drug.
- Male participants, if not surgically sterilized, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 4) from signing the consent form until at least 90 days after the last dose of study drug;
- Have suitable venous access for blood sampling;
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Who cannot join
- Healthy volunteers will be excluded from Part A or Part B of the study if there is evidence of any of the following at screening, Day -1 or pre-dose on Day 1:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
- Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
- Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma);
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia;
- Use of or plans to use systemic immunosuppressive (eg, corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (eg, interferon) during the study or within 4 months prior to the first study drug administration;
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- Liver function test results (ie, AST, ALT, and gamma glutamyl transferase [GGT]) and total bilirubin must not be elevated more than 1.2-fold above the ULN;
- Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
- History of active, latent or inadequately treated tuberculosis (TB) infection;
- Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs;
- Estimated creatinine clearance (CrCl) < 40 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN;
- History of substance abuse or alcohol abuse within 12 months prior to first study drug administration;
- Positive drug or alcohol test results;
- Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol;
- Demonstrated clinically significant (required intervention, eg, emergency room visit, epinephrine administration) allergic reactions (eg, food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the investigator, would interfere with the volunteer's ability to participate in the trial;
- Known hypersensitivity to any of the study drug ingredients;
- Use of any live vaccinations within 30 days prior to the first study drug administration except for the influenza vaccine;
- For women of childbearing potential, a positive serum pregnancy test at screening or a positive urine pregnancy test with confirmatory serum pregnancy test on Day -1;
- Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study drug administration;
- Participation in another investigational clinical trial within 60 days prior to the first study drug administration;
- Any other condition or prior therapy that in the opinion of the PI would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements;
- Is an employee of an investigator or sponsor or an immediate relative of an investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.
Read the detailed description
Part A: 35 healthy volunteers will be enrolled in a total of 5 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
Part B: 21 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
- Conditions
- Ulcerative Colitis
- Being tested
- NX-13 250 mg, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-13 250 mgDrug
Dose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A.
It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days.
PlaceboDrug
Dose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A.
It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days.
| Study group | Role | What they receive |
|---|---|---|
| NX-13 250mg | Experimental | Dose escalation in Part A will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. A dose level will only be evaluated in Part B if determined to be safe and tolerable in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. NX-13 dose levels to be evaluated in Part B will be in the range of 500 to 4000 mg. Receives: Drug: NX-13 250 mg |
| Placebo | Placebo comparator | Dose escalation in Part A will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. A dose level will only be evaluated in Part B if determined to be safe and tolerable in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. NX-13 dose levels to be evaluated in Part B will be in the range of 500 to 4000 mg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs)
Specific assessments to evaluate treatment safety and tolerability include the following: the incidence, severity, and relationship of AEs
Measured: Part A: 37 days Part B: 44 days
Incidence of abnormal Physical examination findings
Specific assessments to evaluate treatment safety and tolerability include the following: physical examinations
Measured: Part A: 37 days Part B: 44 days
Measurement of body weight (Part B only)
Specific assessments to evaluate treatment safety and tolerability include the following: measurement of body weight (Part B only)
Measured: Part A: 37 days Part B: 44 days
Incidence of abnormal clinical laboratory test results
Specific assessments to evaluate treatment safety and tolerability include the following: change from baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters)
Measured: Part A: 37 days Part B: 44 days
Incidence of abnormal ECG results
Specific assessments to evaluate treatment safety and tolerability include the following: 12-lead ECG
Measured: Part A: 37 days Part B: 44 days
Incidence of abnormal vital signs
Specific assessments to evaluate treatment safety and tolerability include the following: vital signs
Measured: Part A: 37 days Part B: 44 days
Secondary outcomes (4)
Plasma concentration of NX-13
Blood samples for pharmacokinetic (PK) analysis will be collected prior to dosing and at several timepoints up to 48 hours post-dose. Plasma concentrations of NX-13 will be determined at each timepoint and used to calculate PK parameters.
Measured: Part A: 37 days Part B: 44 days
Urine concentration of NX-13
Urine samples for analysis of NX-13 concentrations may also be collected prior to dosing and within 0-48 hours post-dose.
Measured: Part A: 37 days Part B: 44 days
Fecal concentration of NX-13
Fecal samples for analysis of NX-13 concentrations may also be collected prior to dosing and within 24-48 hours post-dose.
Measured: Part A: 37 days Part B: 44 days
Measurement of NX-13 levels in stool
A small stool sample will be collected pre and post-dose for the measurement of calprotectin in the feces.
Changes in fecal calprotectin levels following administration of NX-13 will be evaluated. Elevated fecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation.
Measured: Part A: 37 days Part B: 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start10 Jul 2020
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Model description
- This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee. Part A: 35 healthy volunteers will be enrolled in a total of 5 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo. Part B: 21 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landos Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Lichtiger, MD, Study director, Landos Biopharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458805
- Sponsor's protocol ID
- NX-13-1a
- Status last verified
- Mar 2022
- First submitted
- 16 Jun 2020
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04458805
- Acronym / sponsor ID
- NX-13-1a
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Landos Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 7 Jul 2020 (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, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.
Detailed description
Part A: 35 healthy volunteers will be enrolled in a total of 5 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
Part B: 21 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee. Part A: 35 healthy volunteers will be enrolled in a total of 5 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo. Part B: 21 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enroll 7 participants with 5 participants randomized to receive NX-13 and 2 participants randomized to receive placebo.
| Arm | Type | Receives |
|---|---|---|
| NX-13 250mg | Experimental | Drug: NX-13 250 mgDose escalation in Part A will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. A dose level will only be evaluated in Part B if determined to be safe and tolerable in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. NX-13 dose levels to be evaluated in Part B will be in the range of 500 to 4000 mg. |
| Placebo | Placebo comparator | Drug: PlaceboDose escalation in Part A will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. A dose level will only be evaluated in Part B if determined to be safe and tolerable in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. NX-13 dose levels to be evaluated in Part B will be in the range of 500 to 4000 mg. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Healthy volunteers will be included in Part A or Part B of the study if they satisfy all the following criteria:
Key exclusion criteria (22 listed)
- Healthy volunteers will be excluded from Part A or Part B of the study if there is evidence of any of the following at screening, Day -1 or pre-dose on Day 1:
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 |
|---|---|---|
| NX-13 250 mgDose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. | Drug | NX-13 250mg |
| PlaceboDose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A. It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days. | Drug | Placebo |
Primary outcome
Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs)
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: the incidence, severity, and relationship of AEs
Incidence of abnormal Physical examination findings
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: physical examinations
Measurement of body weight (Part B only)
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: measurement of body weight (Part B only)
Incidence of abnormal clinical laboratory test results
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: change from baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters)
Incidence of abnormal ECG results
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: 12-lead ECG
Incidence of abnormal vital signs
Time frame: Part A: 37 days Part B: 44 days
Specific assessments to evaluate treatment safety and tolerability include the following: vital signs
4 secondary outcomes
Plasma concentration of NX-13
Time frame: Part A: 37 days Part B: 44 days
Urine concentration of NX-13
Time frame: Part A: 37 days Part B: 44 days
Fecal concentration of NX-13
Time frame: Part A: 37 days Part B: 44 days
Measurement of NX-13 levels in stool
Time frame: Part A: 37 days Part B: 44 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 10 Mar 2022.
- 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.
Simon Lichtiger, MD study director
Landos Biopharma 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 NX-13 250 mg in people with Ulcerative Colitis, run by Landos Biopharma Inc. at 1 site in Australia.
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 23 inclusion and 22 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 Mar 2022. 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 Australia. 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?
Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs) (time frame: Part A: 37 days Part B: 44 days). The study lists 6 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 10 Mar 2022.