Chronic Inflammatory DiseasePhase 1NCT05323110
Study of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers
A Phase 1 study testing CBS001 in people with Chronic Inflammatory Disease, run by Capella Bioscience Ltd at 1 site in United Kingdom.
Trial summary
A Phase 1, first in human (FIH), single-centre, double-blind, randomized, placebo-controlled, dose escalating trial to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of CBS001 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Disease
- What is being tested?
- CBS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2022to 22 Aug 2023
- 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
- Male or female healthy volunteer.
- Aged 18-65 years.
- A body mass index (BMI; Quetelet index) in the range 18.0-30.9. Body Mass Index = weight (kg)/(height[m]^2
- Ability to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form (ICF), and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agree to follow the contraception requirements of the trial
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- Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication or until the final follow-up visit (whichever is longer).
- Registered with a General Practitioner (GP) in the United Kingdom.
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
Who cannot join
- Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Isolated bilirubin > 1.5 x upper limit of normal (ULN). Isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35% indicative of Gilbert's syndrome.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, allergic diseases such as asthma or atopic dermatitis requiring medication, or history of any psychotic mental illness.
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to any CBS001 excipient.
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- Use of a prescription medicine (except hormone contraceptives or hormone replacement therapy [HRT] in women) during the 28 days before the (first) dose of trial medication, or use of an over-the-counter medicine (except acetaminophen [paracetamol], dietary supplement, or herbal remedy) including St John's Wort during the 7 days before the (first) dose of trial medication.
- Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before [first] admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
- Receipt of an approved or investigational biological product within the 12 months before screening.
- Receipt of a vaccination (except COVID-19 vaccine) within 28 days before (first) dose of trial medication, or planned vaccination during the study.
- Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly, or more than 10 cigarettes or 6.25 g of tobacco daily.
- Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. Repeat measurements are permitted if values are borderline (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if requested
- Corrected QT interval (QTcF) value greater than 450 msec (men) or greater than 470 msec (women) measured on 12-lead ECG at the screening examination. Triplicate measurements will be made, and a mean value used to determine eligibility. A repeat (in triplicate) is also allowed on 1 occasion for determination of eligibility. Participants can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Evidence of drug abuse on urine testing.
- Positive test for hepatitis B, hepatitis C (unless has received curative antiviral treatment and has a negative polymerase chain reaction [PCR] for viral load) or HIV. Loss of more than 400 mL blood during the 3 months before the study, eg as a blood donor.
- Objection by GP to volunteer entering study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single- and Multiple-ascending Doses of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers
A Phase 1, first in human (FIH), single-centre, double-blind, randomized, placebo-controlled, dose escalating trial to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of CBS001 in healthy subjects. The study will be conducted in 2 parts:
Part A: Single ascending intravenous (IV) doses of CBS001 Part B: Multiple ascending IV doses of CBS001
- Conditions
- Chronic Inflammatory Disease
- Being tested
- CBS001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBS001Drug
Intravenously administered, humanised anti-LIGHT IgG monoclonal antibody.
PlaceboDrug
CBS001 matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cohort 1A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 2A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 3A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 4A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 5A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 6A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 7A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 8A | Experimental | Single dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part B - Cohort 1B | Experimental | Multiple dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part B - Cohort 2B | Experimental | Multiple dose cohort Receives: Drug: CBS001; Drug: Placebo |
| Part A - Cohort 3B | Experimental | Multiple dose cohort Receives: Drug: CBS001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part A)
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: Up to Day 190
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part B)
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: Up to Day 247
Secondary outcomes (4)
CBS001 plasma evaluation over time (Part A)
CBS001 plasma concentrations will be measured at specified visits
Measured: Up to Day 190
CBS001 plasma evaluation over time (Part B)
CBS001 plasma concentrations will be measured at specified visits
Measured: Up to Day 247
Antibodies against CBS001 in serum (Part A)
Immunogenicity
Measured: Up to Day 190
Antibodies against CBS001 in serum (Part B)
Immunogenicity
Measured: Up to Day 247
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start14 Apr 2022
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Why it stopped: Portfolio reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capella Bioscience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323110
- Sponsor's protocol ID
- CBS001-01
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single- and Multiple-ascending Doses of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05323110
- Acronym / sponsor ID
- CBS001-01
- Conditions
- Chronic Inflammatory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Portfolio reprioritization
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Capella Bioscience LtdIndustry (pharma, biotech, devices)
- Collaborators
- Centessa Pharmaceuticals plc
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 12 Apr 2022 (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.
A Phase 1, first in human (FIH), single-centre, double-blind, randomized, placebo-controlled, dose escalating trial to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of CBS001 in healthy subjects. The study will be conducted in 2 parts:
Part A: Single ascending intravenous (IV) doses of CBS001 Part B: Multiple ascending IV doses of CBS001
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A - Cohort 1A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 2A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 3A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 4A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 5A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 6A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 7A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part A - Cohort 8A | Experimental | Drug: CBS001, Drug: PlaceboSingle dose cohort |
| Part B - Cohort 1B | Experimental | Drug: CBS001, Drug: PlaceboMultiple dose cohort |
| Part B - Cohort 2B | Experimental | Drug: CBS001, Drug: PlaceboMultiple dose cohort |
| Part A - Cohort 3B | Experimental | Drug: CBS001, Drug: PlaceboMultiple dose cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female healthy volunteer.
- Aged 18-65 years.
- A body mass index (BMI; Quetelet index) in the range 18.0-30.9. Body Mass Index = weight (kg)/(height[m]^2
- Ability to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form (ICF), and after having the opportunity to discuss the trial with the investigator or their delegate.
Key exclusion criteria (17 listed)
- Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Isolated bilirubin > 1.5 x upper limit of normal (ULN). Isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35% indicative of Gilbert's syndrome.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, allergic diseases such as asthma or atopic dermatitis requiring medication, or history of any psychotic mental illness.
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 |
|---|---|---|
| CBS001Intravenously administered, humanised anti-LIGHT IgG monoclonal antibody. | Drug | Part A - Cohort 1A, Part A - Cohort 2A, Part A - Cohort 3A, Part A - Cohort 3B, Part A - Cohort 4A, Part A - Cohort 5A, Part A - Cohort 6A, Part A - Cohort 7A, Part A - Cohort 8A, Part B - Cohort 1B, Part B - Cohort 2B |
| PlaceboCBS001 matched placebo | Drug | Part A - Cohort 1A, Part A - Cohort 2A, Part A - Cohort 3A, Part A - Cohort 3B, Part A - Cohort 4A, Part A - Cohort 5A, Part A - Cohort 6A, Part A - Cohort 7A, Part A - Cohort 8A, Part B - Cohort 1B, Part B - Cohort 2B |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part A)
Time frame: Up to Day 190
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part B)
Time frame: Up to Day 247
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
4 secondary outcomes
CBS001 plasma evaluation over time (Part A)
Time frame: Up to Day 190
CBS001 plasma evaluation over time (Part B)
Time frame: Up to Day 247
Antibodies against CBS001 in serum (Part A)
Time frame: Up to Day 190
Antibodies against CBS001 in serum (Part B)
Time frame: Up to Day 247
Results and safety
The study was stopped early (reason given: Portfolio reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CBS001 in people with Chronic Inflammatory Disease, run by Capella Bioscience Ltd at 1 site in United Kingdom.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 22 Sep 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 Kingdom. 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. 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 was stopped early (reason given: Portfolio reprioritization). Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part A) (time frame: Up to Day 190). 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 22 Sep 2023.