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

NCT04818229 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CBP-307AU002
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (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.

  From Baseline to Day 16

Secondary Outcomes (18)

• Change-from-baseline Heart Rate (HR)

  From Baseline at Day 16

• Change-from-baseline PR

  From Baseline at Day 16

• Change-from-baseline QRS

  From Baseline at Day 16

• Placebo-corrected Change-from-baseline HR

  From Baseline to Day 16

• Placebo-corrected Change-from-baseline QTcF

  From Baseline to Day 16

Study Arms (3)

Investigational Group 1

EXPERIMENTAL

Therapeutic and supratherapeutic multiple oral doses of CBP-307.

Drug: CBP-307; Drug: Placebo-matched CBP-307

Investigational Group 2A

PLACEBO COMPARATOR

Moxifloxacin (positive control for method validation) and Placebo oral administration.

Drug: Moxifloxacin (Avelox); Drug: Placebo-matched Moxifloxacin

Investigational Group 2B

PLACEBO COMPARATOR

Moxifloxacin (positive control for method validation) and Placebo oral administration.

Drug: Moxifloxacin (Avelox); Drug: Placebo-matched Moxifloxacin

Interventions

CBP-307 DRUG

CBP-307 capsules oral administration.

Investigational Group 1

Placebo-matched CBP-307 DRUG

Placebo-matched CBP-307 capsules oral administration.

Investigational Group 1

Moxifloxacin (Avelox) DRUG

Moxifloxacin tablets oral administration。

Investigational Group 2A; Investigational Group 2B

Placebo-matched Moxifloxacin DRUG

Placebo-matched Moxifloxacin tablets oral administration.

Investigational Group 2A; Investigational Group 2B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Connect Biopharma Australia Pty Ltd: lead

Study Sites (2)

Clinical Pharmacology of Miami (CPMI), LLC

Hialeah, Florida, 33014, United States

Location

CMAX

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Chin Lee, MD Chief Medial Officer
• Organization: Connect Biopharma

clee@connectpharm.com

+1 650 676 9617

Study Officials

• Australia Connect

  Connect Biopharma Australia Pty Ltd

  STUDY DIRECTOR

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: June 1, 2021
• Primary Completion: March 20, 2022
• Study Completion: March 30, 2022
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (1)