Healthy VolunteersPhase 1NCT03802292
First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23
A Phase 1 study testing YQ23 in people with Healthy Volunteers, run by New Beta Innovation Limited at 1 site in United Kingdom.
Trial summary
This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- YQ23
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2019to 20 Nov 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any ethnic origin, between 18 and 50 years of age, inclusive.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, and body weight between 50 and 100 kg, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check in, as assessed by the Investigator (or designee).
- Females of non-childbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as at least 12 months postcessation of menses without an alternative medical cause and follicle stimulating hormone level ≥ 40 mIU/mL). Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol.
- Able to comprehend and willing to sign an Informed Consent Form and to abide by the study restrictions.
- Subjects must agree to receive a bovine product.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance (excluding non-active hay fever), unless approved by the Investigator (or designee).
- Any abnormality in the 12-lead ECG that, in the opinion of the Investigator (or designee), increases the risk of participating in the study.
- Any clinically relevant findings on echocardiography, including left ventricular ejection fraction < 50% at baseline.
- Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 bpm, respectively, or lower than 90/50 mmHg and 40 bpm, respectively, at Screening or Check-in, confirmed by a repeat measurement.
- Liver function test results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and/or bilirubin > 1.5 x Upper Limit of Normal (ULN) at Screening or Check-in confirmed by repeat measurement.
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- Total red blood cell count, total white blood cell count, and/or haemoglobin levels outside of the normal reference range at Screening or Check-in, confirmed by repeat measurement.
- History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
- Alcohol consumption of > 21 units per week for males and > 14 units for females.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
- Use or intend to use any prescription medications/products other than hormone replacement therapy (HRT), oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any non-prescription medications/products (with the exception of vitamins/mineral supplements) and phytotherapeutic/herbal/plant derived preparations within 7 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Smoke more than 10 cigarettes or use the equivalent tobacco or nicotine containing products per day.
- Receipt of blood products within 2 months prior to Check in.
- Receipt of bovine Haemoglobin-based Oxygen Carrier (HBOC) or other HBOC in the past.
- Donation of blood from 3 months prior to Screening, plasma from 7 days prior to Screening, or platelets from 6 weeks prior to Screening, or donations on more than 2 occasions within the 12 months preceding dosing.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study.
- Have known allergies to bovine products.
- Are vegetarians.
- Subjects who have had a clinically significant illness as determined by the Investigator within 4 weeks of the start of dose administration.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-In-Man, Phase I, Single-Blind, Placebo-Controlled, Ascending Single Dose Study of Intravenous YQ23 in Healthy Male and Female Subjects to Assess Safety, Tolerability, and Pharmacokinetics
This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.
Read the detailed description
This is a first-in-man, phase 1, single-blind, randomized, placebo-controlled study in healthy volunteers. It will be conducted at a single centre and will enroll approximately 64 subjects. Subjects will either receive a single dose of study drug or placebo in a 3:1 ratio. Eight dose levels of YQ23 will be evaluated.
Each dose level group will be divided into 2 cohorts, with each cohort being dosed at last 24 hours apart. The leading cohort will comprise of 2 subjects, with 1 subject receiving YQ23 and 1 subject receiving placebo. The remaining cohort will comprise of 6 subjects, with 5 receiving YQ23 and 1 receiving placebo.
Safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK samples will be collected.
- Conditions
- Healthy Volunteers
- Being tested
- YQ23, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YQ23Biological
Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated
Matching PlaceboBiological
Single dose of the matching placebo delivered via intravenous route.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose YQ23 | Active comparator | Not described Receives: Biological: YQ23 |
| Single Dose Placebo | Placebo comparator | Not described Receives: Biological: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the incidence of Treatment-emergent Adverse Events (TEAE)
Number of TEAEs will be listed according to the severity (mild, moderate, severe) as assessed by the Investigator.
Measured: From the time of signing the Informed Consent Form to final discharge from the study (approximately 8 weeks)
Safety as assessed by the incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results
All serum biochemistry, haematology, and urinalysis data outside the clinical reference ranges will be listed by parameter and treatment.
Measured: From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Safety as assessed by 12-lead electrocardiogram (ECG)
ECG parameters such as PR, QRS, QT and QTcF in milliseconds will be recorded. Clinically significant abdominal findings will be reported as Adverse Events (AE).
Measured: From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Safety as assessed by echocardiogram
Clinically significant abnormal echocardiogram findings will be recorded as AEs.
Measured: From the time of signing the Informed Consent Form to D2 visit (approximately 30 days)
Safety as assessed by vital sign measurement of blood pressure
Systolic and Diastolic blood pressure (in mmHg) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Measured: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Safety as assessed by vital sign measurement of pulse rate
Pulse rate (in beats/min) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Measured: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Safety as assessed by vital sign measurement of oral body temperature
Body temperature (in degree Celsius) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Measured: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Safety as assessed by local tolerability assessment: pain
The intravenous (IV) infusion site will be assessed for pain according to the following scale [Grade 0=none, 1=does not interfere with activity, 2=interferes with activity or requires repeated use of non-narcotic pain medication, 3=prevent daily activity or requires repeated use of narcotic pain medication, 4=requires medical intervention greater than analgesia]. Grade 3 or above will be recorded as AE.
Measured: From the time before dosing to D3 post dose (3 days)
Safety as assessed by local tolerability assessment: edema
The intravenous (IV) infusion site will be assessed for edema according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm and not interfere with activity, 2=51 to 100mm, or interferes with activity, 3=more than 100mm, and interferes with daily activity, 4=necrosis]. Grade 3 or above will be recorded as AE.
Measured: From the time before dosing to D3 post dose (3 days)
Safety as assessed by local tolerability assessment: erythema intensity
The intravenous (IV) infusion site will be assessed for erythema intensity according to the following scale [Grade 0=None, 1=light pink, 2=pinkish red, 3=intense red]. Grade 3 or above will be recorded as AE.
Measured: From the time before dosing to D3 post dose (3 days)
Safety as assessed by local tolerability assessment: erythema size
The intravenous (IV) infusion site will be assessed for erythema size according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm, 2=51 to 100mm, 3=more than 100mm, 4=necrosis or exfoliative dermatitis]. Grade 3 or above will be recorded as AE.
Measured: From the time before dosing to D3 post dose (3 days)
Secondary outcomes (2)
Pharmacokinetics of YQ23 as assessed by Area under curve (AUC) on all subjects
Plasma levels of YQ23 will be serially evaluated following dosing of study drug, and the AUC will be calculated.
Measured: From study Day 1 (dosing of study drug) until Day 4 of trial participation.
Pharmacokinetics of YQ23 as assessed by the maximum concentration of YQ23 on all subjects
Plasma levels of YQ23 will be serially evaluated following dosing of study drug, and the maximum plasma concentration (Cmax) will be calculated.
Measured: From study Day 1 (dosing of study drug) until Day 4 of trial participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start16 Jan 2019
- Primary completion20 Sep 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study to determine the safe dose level.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Beta Innovation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Billy Lau, PhD, Study director, New Beta Innovation Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802292
- Sponsor's protocol ID
- NBI(CT)-YQ23-2015-001
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Man, Phase I, Single-Blind, Placebo-Controlled, Ascending Single Dose Study of Intravenous YQ23 in Healthy Male and Female Subjects to Assess Safety, Tolerability, and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT03802292
- Acronym / sponsor ID
- NBI(CT)-YQ23-2015-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- New Beta Innovation LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 14 Jan 2019 (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 study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.
Detailed description
This is a first-in-man, phase 1, single-blind, randomized, placebo-controlled study in healthy volunteers. It will be conducted at a single centre and will enroll approximately 64 subjects. Subjects will either receive a single dose of study drug or placebo in a 3:1 ratio. Eight dose levels of YQ23 will be evaluated.
Each dose level group will be divided into 2 cohorts, with each cohort being dosed at last 24 hours apart. The leading cohort will comprise of 2 subjects, with 1 subject receiving YQ23 and 1 subject receiving placebo. The remaining cohort will comprise of 6 subjects, with 5 receiving YQ23 and 1 receiving placebo.
Safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK samples will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Dose escalation study to determine the safe dose level.
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose YQ23 | Active comparator | Biological: YQ23 |
| Single Dose Placebo | Placebo comparator | Biological: Matching Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females, of any ethnic origin, between 18 and 50 years of age, inclusive.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, and body weight between 50 and 100 kg, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check in, as assessed by the Investigator (or designee).
- Females of non-childbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as at least 12 months postcessation of menses without an alternative medical cause and follicle stimulating hormone level ≥ 40 mIU/mL). Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol.
- Able to comprehend and willing to sign an Informed Consent Form and to abide by the study restrictions.
Key exclusion criteria (25 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance (excluding non-active hay fever), unless approved by the Investigator (or designee).
- Any abnormality in the 12-lead ECG that, in the opinion of the Investigator (or designee), increases the risk of participating in the study.
- Any clinically relevant findings on echocardiography, including left ventricular ejection fraction < 50% at baseline.
- Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 bpm, respectively, or lower than 90/50 mmHg and 40 bpm, respectively, at Screening or Check-in, confirmed by a repeat measurement.
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 |
|---|---|---|
| YQ23Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated | Biological | Single Ascending Dose YQ23 |
| Matching PlaceboSingle dose of the matching placebo delivered via intravenous route. | Biological | Single Dose Placebo |
Primary outcome
Safety as assessed by the incidence of Treatment-emergent Adverse Events (TEAE)
Time frame: From the time of signing the Informed Consent Form to final discharge from the study (approximately 8 weeks)
Number of TEAEs will be listed according to the severity (mild, moderate, severe) as assessed by the Investigator.
Safety as assessed by the incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results
Time frame: From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
All serum biochemistry, haematology, and urinalysis data outside the clinical reference ranges will be listed by parameter and treatment.
Safety as assessed by 12-lead electrocardiogram (ECG)
Time frame: From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
ECG parameters such as PR, QRS, QT and QTcF in milliseconds will be recorded. Clinically significant abdominal findings will be reported as Adverse Events (AE).
Safety as assessed by echocardiogram
Time frame: From the time of signing the Informed Consent Form to D2 visit (approximately 30 days)
Clinically significant abnormal echocardiogram findings will be recorded as AEs.
Safety as assessed by vital sign measurement of blood pressure
Time frame: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Systolic and Diastolic blood pressure (in mmHg) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Safety as assessed by vital sign measurement of pulse rate
Time frame: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Pulse rate (in beats/min) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Safety as assessed by vital sign measurement of oral body temperature
Time frame: From From the time of signing the Informed Consent Form to D8 visit (approximately 36 days)
Body temperature (in degree Celsius) which is outside the clinical reference ranges and considered as clinically significant will be reported as AE.
Safety as assessed by local tolerability assessment: pain
Time frame: From the time before dosing to D3 post dose (3 days)
The intravenous (IV) infusion site will be assessed for pain according to the following scale [Grade 0=none, 1=does not interfere with activity, 2=interferes with activity or requires repeated use of non-narcotic pain medication, 3=prevent daily activity or requires repeated use of narcotic pain medication, 4=requires medical intervention greater than analgesia]. Grade 3 or above will be recorded as AE.
Safety as assessed by local tolerability assessment: edema
Time frame: From the time before dosing to D3 post dose (3 days)
The intravenous (IV) infusion site will be assessed for edema according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm and not interfere with activity, 2=51 to 100mm, or interferes with activity, 3=more than 100mm, and interferes with daily activity, 4=necrosis]. Grade 3 or above will be recorded as AE.
Safety as assessed by local tolerability assessment: erythema intensity
Time frame: From the time before dosing to D3 post dose (3 days)
The intravenous (IV) infusion site will be assessed for erythema intensity according to the following scale [Grade 0=None, 1=light pink, 2=pinkish red, 3=intense red]. Grade 3 or above will be recorded as AE.
Safety as assessed by local tolerability assessment: erythema size
Time frame: From the time before dosing to D3 post dose (3 days)
The intravenous (IV) infusion site will be assessed for erythema size according to the following scale [Grade 0=0 to 24mm, 1=25 to 50mm, 2=51 to 100mm, 3=more than 100mm, 4=necrosis or exfoliative dermatitis]. Grade 3 or above will be recorded as AE.
2 secondary outcomes
Pharmacokinetics of YQ23 as assessed by Area under curve (AUC) on all subjects
Time frame: From study Day 1 (dosing of study drug) until Day 4 of trial participation.
Pharmacokinetics of YQ23 as assessed by the maximum concentration of YQ23 on all subjects
Time frame: From study Day 1 (dosing of study drug) until Day 4 of trial participation.
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 3 Mar 2021.
- 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.
Billy Lau, PhD study director
New Beta Innovation Limited
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 YQ23 in people with Healthy Volunteers, run by New Beta Innovation Limited 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 6 inclusion and 25 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 3 Mar 2021. 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. 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?
Safety as assessed by the incidence of Treatment-emergent Adverse Events (TEAE) (time frame: From the time of signing the Informed Consent Form to final discharge from the study (approximately 8 weeks)). The study lists 11 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 3 Mar 2021.