Healthy Study ParticipantsPhase 1NCT04444466
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
A Phase 1 study testing UCB8600 in people with Healthy Study Participants and Chronic Spontaneous Urticaria, run by UCB Biopharma SRL at 1 site in Bulgaria.
Trial summary
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants, Chronic Spontaneous Urticaria
- What is being tested?
- UCB8600
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Jun 2020to 2 Aug 2021
- 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
- Applicable to Parts A-D
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent
- Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests at the Screening Visit
- Body weight 45 kg or greater and body mass index (BMI) within the range 19 and 30 kg/m^2 (inclusive)
- Part B-specific
- Study participants must have a Screening serum immunoglobulin E (IgE) of ≥30 kU/L and ≤700 kU/L for inclusion in Cohort 1 through Cohort 4a and >700 kU/L for inclusion in Cohort 4b
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- Study participants must be documented to be sensitized to at least 1 common aeroallergen confirmed by (skin prick test (SPT) at Screening)
- Part C-specific
- Study participants must have a diagnosis of chronic spontaneous urticaria (CSU) diagnosed by a dermatologist, allergist or clinical immunologist and have persistent symptoms most days of the week for the last 6 weeks despite regular use of an H1 antihistamine according to the EAACI/GA²LEN/EDF/WAO guideline
- Study participants must have a documented 7-day Urticaria Assessment Score (UAS7) score of 16 or above and an 7-day Itch Severity Score (ISS7) of 8 or above at Visit 2 (Day -1, Admission)
- Study participants must have a Screening serum immunoglobulin E (IgE) of ≥30 kU/L
Who cannot join
- Applicable to Parts A-D
- Participant has any (acute or chronic [including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Study participant has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula (QTcF) >450 msec , left bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or Day -1 (Admission)
- A history of additional risk factors for Torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
- Study participant has a history of atopy, allergic rhinitis, urticaria, angioedema, asthma, food allergies, or anaphylaxis
- Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
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- Study participant has a history of drug allergy or other allergy that, in the opinion of the investigator or UCB Study Physician, contraindicates his/her participation
- Study participants with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All participants will be screened at Screening. If stool testing is positive for pathogenic organism, the participants will not enter Treatment Period and will not be allowed to rescreen
- Study participant has received prescription or nonprescription medicines (including over-the-counter medicines and herbal and dietary supplements [including St John's Wort]) that have been taken within 14 days prior to Screening. Drugs that are strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 and/or P-glycoprotein (Pgp) are prohibited
- The use of concomitant medications that prolong the QT/QTc interval
- Study participant has donated more than 500 mL of blood or blood products within 90 days prior to Admission (Day -1) or plans to donate blood during the study (20 weeks post Screening)
- Study participant has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of UCB8600
- Part B-specific
- Study participant has:
- a history of angioedema, severe asthma, severe food allergies, or anaphylaxis
- a personal or family history of cardiomyopathy
- A Screening forced expiratory volume (FEV1) <80% predicted (highest of 3)
- Study participant has:
- Allergen immunotherapy, also known as desensitization or hyposensitization at a maintenance licensed dose (depending on the type of immunotherapy [subcutaneous or sublingual]) for ≥3 months prior to Screening and then throughout the study
- Severe positive reaction to Screening skin prick test
- Topical or systemic corticosteroids, including high dose oral (>5 mg prednisolone), in the past 14 days prior to Screening and throughout the study
- Topical immunosuppressants in the past 14 days prior to Screening and throughout the study
- Tricyclic antidepressants, prescription antihistamines, over-the-counter antihistamines, and heartburn medications in the past 14 days prior to Admission
- Systemic immunosuppressants such as azathioprine, methotrexate, cyclosporine, and mycophenolate mofetil in the past 4 weeks prior to Screening and throughout the study
- Biologics such as omalizumab for the past 6 months prior to Screening and throughout the study
- Part C-specific
- Study participant has:
- a history of angioedema, severe asthma, severe food allergies, or anaphylaxis
- a personal or family history of cardiomyopathy
- Study participants with a serum IgE level of >1000 kU/L
- A screening FEV1 <80% predicted (average of 3)
- Allergen immunotherapy, also known as desensitization or hyposensitization at a maintenance licensed dose (depending on the type of immunotherapy [subcutaneous or sublingual]) for ≥3 months prior to Screening and then throughout the study
- Topical or systemic corticosteroids, including high dose oral (>5 mg prednisolone), in the past 14 days prior to Screening and throughout the study
- Topical immunosuppressants in the past 14 days prior to Screening and throughout the study
- Systemic immunosuppressants such as azathioprine, methotrexate, cyclosporine, and mycophenolate mofetil in the past 4 weeks prior to Screening and throughout the study
- Biologics such as omalizumab for the past 6 months prior to Screening and throughout the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.
Read the detailed description
The Study was only open for recruitment of Healthy Study Participants (Part A) prior to termination and did not enroll any patient population.
- Being tested
- UCB8600, Placebo
- Keywords
- Healthy study participants, UCB8600, Phase 1, Chronic spontaneous urticaria, CSU, IgE, Atopic participants, Urticaria, UCB, Food Effect (Part D)
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB8600Drug
Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.
PlaceboOther
Also called PBO
Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.
| Study group | Role | What they receive |
|---|---|---|
| UCB8600 | Experimental | Study participants randomized to this arm will receive various single doses and multiple doses of UCB8600 administered to various cohorts. Receives: Drug: UCB8600 |
| Placebo | Placebo comparator | Study participants randomized to this arm will receive various single doses and multiple doses of Placebo administered to various cohorts. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event is characterized according to the intake of the study medication.
Measured: From Baseline (Day 1) until the End of Study (up to Day 42)
Secondary outcomes (8)
The maximum plasma concentration (Cmax) of a single dose UCB8600
Cmax: Maximum observed plasma concentration
Measured: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
Time to maximum plasma concentration (tmax) of a single dose UCB8600
tmax: Time to maximum observed plasma concentration
Measured: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
The area under the curve (AUC) of a single dose UCB8600
AUC0-infinity: Area under the plasma concentration time curve from time 0 to infinity
Measured: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
The maximum plasma concentration (Cmax) of multiple doses UCB8600
Cmax: Maximum observed plasma concentration
Measured: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
Time to maximum plasma concentration (tmax) of multiple doses UCB8600
tmax: Time to maximum observed plasma concentration
Measured: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 1 of multiple doses UCB8600
AUCtau: Area Under the Curve over a dosing interval
Measured: Plasma samples will be taken on Day 1 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 9 of multiple doses UCB8600
AUCtau: Area Under the Curve over a dosing interval
Measured: Plasma samples will be taken on Day 9 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 14 of multiple doses UCB8600
AUCtau: Area Under the Curve over a dosing interval
Measured: Plasma samples will be taken on Day 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start30 Jun 2020
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Why it stopped: internal company decision; not safety related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444466
- Sponsor's protocol ID
- UP0086
- Other IDs
- 2019-002981-12, 2019
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
- ClinicalTrials.gov ID
- NCT04444466
- Acronym / sponsor ID
- UP0086
- Keywords
- Healthy study participants, UCB8600, Phase 1, Chronic spontaneous urticaria, CSU, IgE, Atopic participants, Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: internal company decision; not safety related
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 23 Jun 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.
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.
Detailed description
The Study was only open for recruitment of Healthy Study Participants (Part A) prior to termination and did not enroll any patient population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cohort design
| Arm | Type | Receives |
|---|---|---|
| UCB8600 | Experimental | Drug: UCB8600Study participants randomized to this arm will receive various single doses and multiple doses of UCB8600 administered to various cohorts. |
| Placebo | Placebo comparator | Other: PlaceboStudy participants randomized to this arm will receive various single doses and multiple doses of Placebo administered to various cohorts. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Applicable to Parts A-D
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent
- Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests at the Screening Visit
- Body weight 45 kg or greater and body mass index (BMI) within the range 19 and 30 kg/m^2 (inclusive)
- Part B-specific
Key exclusion criteria (36 listed)
- Applicable to Parts A-D
- Participant has any (acute or chronic [including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Study participant has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula (QTcF) >450 msec , left bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or Day -1 (Admission)
- A history of additional risk factors for Torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
- Study participant has a history of atopy, allergic rhinitis, urticaria, angioedema, asthma, food allergies, or anaphylaxis
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 |
|---|---|---|
| UCB8600Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period. | Drug | UCB8600 |
| PlaceboAlso: PBOStudy participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600. | Other | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline (Day 1) until the End of Study (up to Day 42)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event is characterized according to the intake of the study medication.
8 secondary outcomes
The maximum plasma concentration (Cmax) of a single dose UCB8600
Time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
Time to maximum plasma concentration (tmax) of a single dose UCB8600
Time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
The area under the curve (AUC) of a single dose UCB8600
Time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
The maximum plasma concentration (Cmax) of multiple doses UCB8600
Time frame: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
Time to maximum plasma concentration (tmax) of multiple doses UCB8600
Time frame: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 1 of multiple doses UCB8600
Time frame: Plasma samples will be taken on Day 1 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 9 of multiple doses UCB8600
Time frame: Plasma samples will be taken on Day 9 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
The area under the curve (AUCtau) over a dosing interval on Day 14 of multiple doses UCB8600
Time frame: Plasma samples will be taken on Day 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
Results and safety
The study was stopped early (reason given: internal company decision; not safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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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.
UCB Cares study director
001 844 599 2273 (UCB)
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 UCB8600 in people with Healthy Study Participants and Chronic Spontaneous Urticaria, run by UCB Biopharma SRL at 1 site in Bulgaria.
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 11 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: stopped early, as of the sponsor's last update on 19 Jul 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 Bulgaria. 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 was stopped early (reason given: internal company decision; not safety related). 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 (TEAEs) (time frame: From Baseline (Day 1) until the End of Study (up to Day 42)). 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 19 Jul 2022.