AzTrials
AzTrials

Autoimmune DiseasesPhase 1NCT04818229

A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects

A Phase 1 study testing CBP-307 and Moxifloxacin (Avelox) in people with Autoimmune Diseases, run by Connect Biopharma Australia Pty Ltd at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Autoimmune Diseases
What is being tested?
CBP-307 and Moxifloxacin (Avelox)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
2 sitesin 2 countries
Study dates
1 Jun 2021to 30 Mar 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Males or females, of any race, between 18 and 60 years of age, inclusive.
  • Body mass index between 18.0 and 30.0 kg/mE2, inclusive.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and confirmed at check-in as assessed by the investigator (or designee).
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. Negative pregnancy test for females of childbearing potential at screening (blood test) and check-in (urine test).
  • Supine diastolic blood pressure between 60 and 90 mmHg and systolic blood pressure between 90 and 140 mmHg (inclusive) at screening on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  • No clinically significant history or presence of ECG findings as judged by the investigator at screening and check-in, including each criterion as listed below:
Show all 13Show fewer
  • Normal sinus rhythm (HR between 55 bpm and 100 bpm inclusive);
  • QTcF interval ≤450 msec for males and females;
  • QRS interval ≤110 msec; and confirmed by manual over-read if >110 msec;
  • PR interval ≤200 msec.
  • Has serum potassium, calcium, and magnesium levels within the normal reference range at screening, as judged by the investigator.
  • Able to swallow multiple tablets (based on subject's verbal confirmation).
  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Who cannot join

  • -
  • Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit unless otherwise stated:
  • Subject is mentally or legally incapacitated or has had significant history of recent mental health issues requiring medication and/or hospitalization at the time of the screening visit or expected during the conduct of the study.
  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). Note: Childhood asthma that is considered recovered or seasonal allergies that are not currently active or requiring treatment are allowed.
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients.
Show all 36Show fewer
  • History of significant multiple and/or severe allergies (eg, latex allergy, band-aids, adhesive dressing, or medical tape), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs.
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs within 6 months prior to the first dose of study drug (uncomplicated appendectomy and hernia repair will be allowed).
  • History or presence of:
  • Hypokalemia, in the opinion of the investigator (or designee);
  • Risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
  • Sick sinus syndrome, second, or third degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities;
  • Repeated or frequent syncope or vasovagal episodes;
  • Hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders.
  • Clinically significant abnormalities (as judged by the investigator in laboratory tests results [out-of-range results confirmed on repeat]), including but not limited to the following parameters:
  • alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than 1.5 × upper limit of normal;
  • hemoglobin <10 g/dL, WBC <3.0 ×10E9/L, neutrophils <1.5 ×10E9/L, lymphocytes <0.8 ×10E9/L and platelets <100 ×10E9/L or >1200 × 10E9/L;
  • History or evidence of alcoholism or drug/chemical abuse within 2 years prior to check-in.
  • Alcohol consumption of >10 units per week for males and females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
  • Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
  • Positive hepatitis panel, positive syphilis test, and/or positive human immunodeficiency virus test.
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 28 days prior to the first dose of study treatment on Day 1. The 28-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
  • Participation in a previous clinical study where subjects received CBP-307.
  • Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 28 days prior to first dose of study treatment on Day 1.
  • Use or intend to use any prescription medications/products within 14 days prior to first dose of study drug (Day 1) and throughout the study, unless deemed acceptable by the investigator (or designee). Note: For females only, the use hormonal contraception, hormone replacement therapy or oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives within 14 days prior to Day 1 is not acceptable, except for Mirena®.
  • Use or intend to use any drugs known to be significant inhibitors or inducers of CYP enzymes and/or P-gp, including St. John's Wort, for days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the investigator or designee to confirm the lack of PK/PD interaction with the study drug.
  • Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
  • Use or intend to use any nonprescription medications/products including antacids, vitamins (especially those containing magnesium, aluminum, iron, or zinc), minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
  • Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
  • Has been on a diet incompatible with the on-study diet (including an extreme diet which resulted in a significant weight change for whatever reason), in the opinion of the investigator, within the 28 days prior to the first dose of study treatment, and throughout the study.
  • Consumption of caffeine/xanthine-containing foods or beverages within 48 hours prior to check-in until discharge.
  • Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
  • Receipt of blood products within 2 months prior to check-in.
  • Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
  • Poor peripheral venous access.
  • Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Clinical Pharmacology of Miami (CPMI), LLC

    Hialeah, Florida, 33014

Other trials in United States

Australia1 site

  • CMAX

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase I, Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Positive-Controlled Study to Investigate the Effects of CBP-307 on the QTc Interval in Healthy Subjects

This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.

Read the detailed description

This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, multi-site, 3-arm study to investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female subjects.

Being tested
CBP-307, Placebo-matched CBP-307, Moxifloxacin (Avelox), Placebo-matched Moxifloxacin
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP-307Drug

    CBP-307 capsules oral administration.

  • Placebo-matched CBP-307Drug

    Placebo-matched CBP-307 capsules oral administration.

  • Moxifloxacin (Avelox)Drug

    Moxifloxacin tablets oral administration。

  • Placebo-matched MoxifloxacinDrug

    Placebo-matched Moxifloxacin tablets oral administration.

Study groups in NCT04818229
Study groupRoleWhat they receive
Investigational Group 1ExperimentalTherapeutic and supratherapeutic multiple oral doses of CBP-307.
Receives: Drug: CBP-307; Drug: Placebo-matched CBP-307
Investigational Group 2APlacebo comparatorMoxifloxacin (positive control for method validation) and Placebo oral administration.
Receives: Drug: Moxifloxacin (Avelox); Drug: Placebo-matched Moxifloxacin
Investigational Group 2BPlacebo comparatorMoxifloxacin (positive control for method validation) and Placebo oral administration.
Receives: Drug: Moxifloxacin (Avelox); Drug: Placebo-matched Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF)

    Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.

    Measured: From Baseline to Day 16

Secondary outcomes (18)

  1. Change-from-baseline Heart Rate (HR)

    Change from Baseline in heart rate (HR).

    Measured: From Baseline at Day 16

  2. Change-from-baseline PR

    Change from Baseline in PR.

    Measured: From Baseline at Day 16

  3. Change-from-baseline QRS

    Change from Baseline in QRS.

    Measured: From Baseline at Day 16

  4. Placebo-corrected Change-from-baseline HR

    Placebo-corrected Change-from-baseline HR based on Change-from-baseline Heart Rate (HR) reported in Outcome Measure 2

    Measured: From Baseline to Day 16

  5. Placebo-corrected Change-from-baseline QTcF

    Placebo-corrected change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) based on Change-from-baseline QTcF reported in Outcome Measure 1

    Measured: From Baseline to Day 16

  6. Placebo-corrected Change-from-baseline PR

    Placebo-corrected change-from-baseline PR based on Change-from-baseline PR reported in Outcome Measure 3

    Measured: From Baseline to Day 16

  7. Placebo-corrected Change-from-baseline QRS

    Placebo-corrected change-from-baseline QRS based on Change-from-baseline QRS reported in Outcome Measure 4

    Measured: From Baseline to Day 16

  8. Categorical Outliers for QTcF

    For categorical outliers, the number (percentage) of subjects as well as timepoints who had increases in absolute QTcF values >450 and ≤480 msec, >480 and ≤500 msec, or >500 msec, and changes from predose baseline of >30 and ≤60 msec, or >60 msec.

    Measured: From Baseline to Day 16

  9. Categorical Outliers for HR

    For categorical outliers, decrease in HR from predose baseline >25% to an HR <50 bpm will be determined.

    Measured: From Baseline to Day 16

  10. Categorical Outliers for PR

    For categorical outliers, increase in PR from predose baseline >25% to a PR > 200 msec will be determined.

    Measured: From Baseline to Day 16

  11. Categorical Outliers for QRS

    For categorical outliers, increase in QRS from predose baseline >25% to a QRS >120 msec will be determined.

    Measured: From Baseline to Day 16

  12. Frequency of Treatment-emergent Changes of T-wave Morphology

    For T-wave morphology, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.

    Measured: From Baseline to Day 16

  13. Frequency of Treatment-emergent Changes of U-wave Presence

    For U-wave presence, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.

    Measured: From Baseline to Day 16

  14. Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)

    Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter.

    Measured: From Baseline to Day 29 ± 2

  15. Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24)

    Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter.

    Measured: From Baseline to Day 29 ± 2

  16. Maximum Observed Concentration (Cmax)

    Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter.

    Measured: From Baseline to Day 29 ± 2

  17. Time of the Maximum Observed Concentration (Tmax)

    Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter.

    Measured: From Baseline to Day 29 ± 2

  18. Incidence and Severity of Adverse Event (AE)

    All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology.

    14.3.1.1 TEAE

    Measured: From Baseline to Day 29 ± 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start1 Jun 2021
  3. Primary completion20 Mar 2022
  4. Study completion30 Mar 2022

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818229
Sponsor's protocol ID
CBP-307AU002
Status last verified
Aug 2024
First submitted
24 Mar 2021
Last updated
4 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBP-307 and Moxifloxacin (Avelox) in people with Autoimmune Diseases, run by Connect Biopharma Australia Pty Ltd at 2 sites in 2 countries.

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 13 inclusion and 36 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, 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?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) (time frame: From Baseline to Day 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818229.

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 4 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in