Critical Limb IschemiaPhase 1/2YANNCT04792008
YQ23 Study in Patients With Critical Limb Ischaemia
A Phase 1/2 study testing YQ23 in people with Critical Limb Ischemia, run by New Beta Innovation Limited at 2 sites in Hong Kong.
Trial summary
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- 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
- 5 participants
- Where
- 2 sitesHong Kong
- Study dates
- 10 Mar 2021to 31 Aug 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CLI (Rutherford Classification stage 4, 5 or 6) including at least one of the following:
- resting ankle systolic pressure (either dorsalis pedis or posterior tibial artery) <=70 mmHg in affected limb
- resting toe systolic pressure <=50 mmHg in affected limb
- TcPO2 <=30 mmHg
- One of the following clinical presentations:
- pain at rest
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- ischaemic ulcer, and/or focal gangrene for at least 2 weeks
- Diagnosis of severe lower extremity peripheral artery occlusive disease as evidenced by either:
- Documented significant stenosis (>=75%) of >=1 of the following arteries: superficial femoral, popliteal, and infra-popliteal arteries, as assessed by imaging test, or
- ABI <=0.80 or TBI <=0.60 of the index leg (in the event of non-compressible ankle arteries) for patients without a prior history of limb revascularization on the index leg, or an ABI <=0.85 or TBI <=0.65 of the index leg (in the event of non-compressible ankle arteries) for patients with a prior history of limb revascularization on the index leg.
- Contraceptive use
- Male patients and their female spouses/partners who are of childbearing potential must agree to use a high effective contraception consisting of two forms of birth control detailed in the protocol during the treatment period and for at least 6 days after the dose of the study treatment and refrain from donating sperm during this period
- A female patient is eligible if she is not pregnant, not breastfeeding, and at least on of the following conditions applies: (i) not a woman of childbearing potential (WOCBP), (ii) A WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 days after the dose of study treatment and refrain from donating ova during this period
- Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and the protocol
Who cannot join
- Patients who have undergone successful revascularisation on the index leg within 4 weeks of the qualifying event
- Patients with estimated life expectancy <12 months
- Acute limb ischaemia due to thromboembolism within 2 weeks of the qualifying event
- Recent myocardial infarction within 30 calendar days prior to signing informed consent
- Recent stroke within 30 calendar days prior to signing informed consent
- Known history of severe congestive heart failure as determined through review of medical history
Show all 25Show fewer
- Haemoglobin <8 g/dL, albumin <3 g/dL or other clinically significant abnormalities in the laboratory tests at screening
- Unwilling to complete follow-up evaluation
- Uncontrolled arterial hypertension with systolic blood pressure (SBP) >180 mmHg and/or diastolic blood pressure (DBP) >100 mmHg at screening
- Patients with history of long QT syndrome or whose QTc (calculated according to Bazett formula QTc = QT/ √RR) >470 ms at screening
- Patients with severe left ventricular dysfunction of <40% at screening
- Patients with clinically significant abnormalities in ECG parameters (other than QTc) or in the physical examination at screening that might comprise patient safety
- History of coagulopathy
- Patients having significant renal impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 as determined by the 4-variable Modification of Diet in Renal Disease (MDRD) equation at Screening, except those patients who are on continuous ambulatory peritoneal dialysis(CAPD) or hemodialysis (HD)
- Significant liver impairment (abnormal Liver Function Tests >3 x upper limit of normal)
- Patients with active Hepatitis B infection (HBsAg positive and HBeAg positive) at screening
- Patient with a positive test for Hepatitis C virus antibody (anti-HCV) at screening
- Patient with known history of infection with human immunodeficiency virus (HIV) or any other active or chronic infection
- Patients with evidence of uncontrolled hypo- or hyperthyroidism
- History active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma)
- Patients unable to provide informed consent
- Known allergy to bovine products
- Receipt of bovine haemoglobin-based oxygen carrier (HBOC) or other HBOC in the past
- Use of an investigational drug or treatment within 12 months prior to signing informed consent; concurrent participation in any other investigational protocol
- Pregnancy and breastfeeding, as well as unwillingness to use effective methods contraception for women of childbearing potential
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
About this study
Official title: A Randomised, Double-Blind, Phase 1b/2a, Placebo-Controlled, Single Dose Study to Evaluate Safety, Tolerability, and Efficacy of YQ23 in Adult Patients With Critical Limb Ischaemia
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. The study also aims to understand how it affects the body and an optional substudy to assess how the human body takes up, breaks down, and clears the study drug.
Eligible patients will be randomised to have a 2:1 chance to receive a single, intravenous, fixed dose of YQ23 or normal saline. Neither the patient nor the study site will know which treatment has been given.
Read more
On the day of YQ23 administration, patients will be asked to stay in the study site for 3 days for safety observation. After discharge, they will be required to visit the study clinic for 3 times in a year to continue safety monitoring and assessment of treatment effect.
Each subject's participation will be about 13 months after signing the informed consent.
Read the detailed description
This is a Phase 1b/2a, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of an investigational product, YQ23, in patients with Critical Limb Ischaemia (CLI) during a follow-up period of 12 months.
Fifty-one patients are planned for enrolment. The study consists of a screening period (up to 28 days), a double-blind treatment period, and a follow-up (12 months). Prior to randomisation, patients diagnosed with CLI will be stratified into:
- Group of patients in whom revascularisation is not planned
- Group of patients with planned revascularisation
Within each group, patients will be randomised in a 2:1 ratio to receive single intravenous infusion of YQ23 120 mg/kg and normal saline, respectively at the study site.
On the day of YQ23 administration, the patient will be admitted to the study site on Day 1 and will be discharged on Day 3. The total duration of participation in the study for each patient is approximately 13 months. Data on the study endpoints will be collected from baseline (pre-dose on Day 1), Day 3, Month 1, 6 and up to 12 months after study treatment infusion.
- Conditions
- Critical Limb Ischemia
- Being tested
- YQ23, Matching placebo
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YQ23Biological
Single dose of 120 mg/kg YQ23 via intravenous route will be evaluated
Matching placeboBiological
Single dose of 0.9% normal saline via intravenous route as matching placebo
| Study group | Role | What they receive |
|---|---|---|
| YQ23 Single dose | Experimental | Two-third of randomized patients will receive YQ23 as active treatment Receives: Biological: YQ23 |
| Placebo Single dose | Placebo comparator | One-third of randomized patients will receive matching placebo Receives: Biological: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single IV dose of YQ23 - adverse and serious adverse events
Incidence of adverse events and serious adverse events
Measured: From the time of signing informed consent through study completion, a duration of 13 months.
Safety and tolerability of single IV dose of YQ23 - abnormal laboratory values
Number of participants with a change in laboratory values of haematology, chemistry or urinalysis which is of clinical significance
Measured: From the time of signing informed consent through study completion, a duration of 13 months.
Safety and tolerability of single IV dose of YQ23 - 12 lead electrocardiogram (ECG)
Number of participants with a change in 12-lead ECG measurements which is of clinical significance
Measured: From the time of signing informed consent through study completion, a duration of 13 months.
Safety and tolerability of single IV dose of YQ23 - vital signs
Number of participants with a change in vital signs of blood pressure, pulse rate, respiratory rate or oral temperature which is of clinical significance
Measured: From the time of signing informed consent through study completion, a duration of 13 months.
Safety and tolerability of single IV dose of YQ23 - physical examinations
Number of participants with a change in physical examination findings which is of clinical significance
Measured: From the time of signing informed consent through study completion, a duration of 13 months.
Safety and tolerability of single IV dose of YQ23 - major adverse limb events (MALE)
The incidence of MALE of interest. MALE include amputation (transtibial or above) or any major vascular intervention in the index limb
Measured: From pre-dose to Month 1
Secondary outcomes (20)
Efficacy of single dose YQ23 as compared to placebo - all cause mortality
Incidence rate of all deaths
Measured: From the time of signing informed consent to Month 12
Efficacy of single dose YQ23 as compared to placebo - amputation free survival
Incidence rate of all amputations
Measured: From pre-dose to Month 12
Efficacy of single dose YQ23 as compared to placebo - MALE of interest
Incidence of MALE of interest
Measured: At month 6 and 12
Efficacy of single dose YQ23 as compared to placebo - Rutherford classification
Change in Rutherford classification
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - visual analogue pain scale
Change in visual analogue pain scale in a one to ten scale - one reported as no pain while 10 as the most intense pain
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing in size
Change in size as measured by length x width x depth in mm
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing by transparent film
Change in size as measured by the number of grids in a wound tracing film
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing 100%
Number of participants to achieve 100% epithelialization
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing by Wound, Ischemia, and Foot Infection (WIFI) classification system
Change in the grading under the WIFI classification system
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - transcutaneous oxygen pressure
Change in transcutaneous oxygen pressure (TcPO2)
Measured: From pre-dose, 2 hours post-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - quality of life score
Change in EuroQol -5 Dimension (EQ-5D) questionnaire
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - ankle brachial index (ABI)
Change in ABI, a ratio of systolic blood pressure at the ankle to that in the arm
Measured: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - toe brachial index (TBI)
Change in TBI, a ratio of systolic blood pressure at the toe to that in the arm
Measured: From pre-dose, Month 1, 6 and 12
An optional substudy to assess the pharmacokinetics of YQ23 - maximum observed concentration (Cmax)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the Cmax
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - time to Cmax
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the time corresponding to occurrence of the Cmax (Tmax)
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - Area under the curve (0 to last)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the area under the plasma concentration-time curve (AUC) - AUC from time 0 to the last measurable time point (AUClast)
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - Area under the curve (0 to infinity)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the area under the plasma concentration-time curve (AUC) - AUC from time 0 extrapolated to infinity (AUCinf)
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - terminal elimination half-life (t1/2)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the t1/2
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - total clearance (CL)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the CL
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/- 6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - volume of distribution during terminal phase (Vz)
Plasma level of YQ23 will be serially evaluated following dosing of the study drug to determine the Vz
Measured: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/- 6) and 48 hours post end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Mar 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: Due to business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Beta Innovation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Billy Lau, Study director, New Beta Innovation Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792008
- Sponsor's protocol ID
- YQ23-19001
- Acronym
- YAN
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2021
- Last updated
- 8 Dec 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Phase 1b/2a, Placebo-Controlled, Single Dose Study to Evaluate Safety, Tolerability, and Efficacy of YQ23 in Adult Patients With Critical Limb Ischaemia
- ClinicalTrials.gov ID
- NCT04792008
- Acronym / sponsor ID
- YAN / YQ23-19001
- Conditions
- Critical Limb Ischemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to business decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- New Beta Innovation LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Mar 2021 (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 is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. The study also aims to understand how it affects the body and an optional substudy to assess how the human body takes up, breaks down, and clears the study drug.
Eligible patients will be randomised to have a 2:1 chance to receive a single, intravenous, fixed dose of YQ23 or normal saline. Neither the patient nor the study site will know which treatment has been given.
On the day of YQ23 administration, patients will be asked to stay in the study site for 3 days for safety observation. After discharge, they will be required to visit the study clinic for 3 times in a year to continue safety monitoring and assessment of treatment effect.
Each subject's participation will be about 13 months after signing the informed consent.
Detailed description
This is a Phase 1b/2a, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of an investigational product, YQ23, in patients with Critical Limb Ischaemia (CLI) during a follow-up period of 12 months.
Fifty-one patients are planned for enrolment. The study consists of a screening period (up to 28 days), a double-blind treatment period, and a follow-up (12 months). Prior to randomisation, patients diagnosed with CLI will be stratified into:
- Group of patients in whom revascularisation is not planned
- Group of patients with planned revascularisation
Within each group, patients will be randomised in a 2:1 ratio to receive single intravenous infusion of YQ23 120 mg/kg and normal saline, respectively at the study site.
On the day of YQ23 administration, the patient will be admitted to the study site on Day 1 and will be discharged on Day 3. The total duration of participation in the study for each patient is approximately 13 months. Data on the study endpoints will be collected from baseline (pre-dose on Day 1), Day 3, Month 1, 6 and up to 12 months after study treatment infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YQ23 Single dose | Experimental | Biological: YQ23Two-third of randomized patients will receive YQ23 as active treatment |
| Placebo Single dose | Placebo comparator | Biological: Matching placeboOne-third of randomized patients will receive matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of CLI (Rutherford Classification stage 4, 5 or 6) including at least one of the following:
- One of the following clinical presentations:
- Diagnosis of severe lower extremity peripheral artery occlusive disease as evidenced by either:
- Contraceptive use
- Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and the protocol
Key exclusion criteria (25 listed)
- Patients who have undergone successful revascularisation on the index leg within 4 weeks of the qualifying event
- Patients with estimated life expectancy <12 months
- Acute limb ischaemia due to thromboembolism within 2 weeks of the qualifying event
- Recent myocardial infarction within 30 calendar days prior to signing informed consent
- Recent stroke within 30 calendar days prior to signing informed consent
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 120 mg/kg YQ23 via intravenous route will be evaluated | Biological | YQ23 Single dose |
| Matching placeboSingle dose of 0.9% normal saline via intravenous route as matching placebo | Biological | Placebo Single dose |
Primary outcome
Safety and tolerability of single IV dose of YQ23 - adverse and serious adverse events
Time frame: From the time of signing informed consent through study completion, a duration of 13 months.
Incidence of adverse events and serious adverse events
Safety and tolerability of single IV dose of YQ23 - abnormal laboratory values
Time frame: From the time of signing informed consent through study completion, a duration of 13 months.
Number of participants with a change in laboratory values of haematology, chemistry or urinalysis which is of clinical significance
Safety and tolerability of single IV dose of YQ23 - 12 lead electrocardiogram (ECG)
Time frame: From the time of signing informed consent through study completion, a duration of 13 months.
Number of participants with a change in 12-lead ECG measurements which is of clinical significance
Safety and tolerability of single IV dose of YQ23 - vital signs
Time frame: From the time of signing informed consent through study completion, a duration of 13 months.
Number of participants with a change in vital signs of blood pressure, pulse rate, respiratory rate or oral temperature which is of clinical significance
Safety and tolerability of single IV dose of YQ23 - physical examinations
Time frame: From the time of signing informed consent through study completion, a duration of 13 months.
Number of participants with a change in physical examination findings which is of clinical significance
Safety and tolerability of single IV dose of YQ23 - major adverse limb events (MALE)
Time frame: From pre-dose to Month 1
The incidence of MALE of interest. MALE include amputation (transtibial or above) or any major vascular intervention in the index limb
20 secondary outcomes
Efficacy of single dose YQ23 as compared to placebo - all cause mortality
Time frame: From the time of signing informed consent to Month 12
Efficacy of single dose YQ23 as compared to placebo - amputation free survival
Time frame: From pre-dose to Month 12
Efficacy of single dose YQ23 as compared to placebo - MALE of interest
Time frame: At month 6 and 12
Efficacy of single dose YQ23 as compared to placebo - Rutherford classification
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - visual analogue pain scale
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing in size
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing by transparent film
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing 100%
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - wound healing by Wound, Ischemia, and Foot Infection (WIFI) classification system
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - transcutaneous oxygen pressure
Time frame: From pre-dose, 2 hours post-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - quality of life score
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - ankle brachial index (ABI)
Time frame: From pre-dose, Month 1, 6 and 12
Efficacy of single dose YQ23 as compared to placebo - toe brachial index (TBI)
Time frame: From pre-dose, Month 1, 6 and 12
An optional substudy to assess the pharmacokinetics of YQ23 - maximum observed concentration (Cmax)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - time to Cmax
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - Area under the curve (0 to last)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - Area under the curve (0 to infinity)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - terminal elimination half-life (t1/2)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/-6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - total clearance (CL)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/- 6) and 48 hours post end of infusion
An optional substudy to assess the pharmacokinetics of YQ23 - volume of distribution during terminal phase (Vz)
Time frame: From pre-dose, immediately after end of infusion, 0.25, 0.5, 1, 2, 6, 18 (+/- 6) and 48 hours post end of infusion
Results and safety
The study was stopped early (reason given: Due to business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 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.
Billy Lau study director
New Beta Innovation Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YQ23 in people with Critical Limb Ischemia, run by New Beta Innovation Limited at 2 sites in Hong Kong.
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 14 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: stopped early, as of the sponsor's last update on 8 Dec 2023. 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 Hong Kong. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Due to business decision). 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?
Safety and tolerability of single IV dose of YQ23 - adverse and serious adverse events (time frame: From the time of signing informed consent through study completion, a duration of 13 months.). The study lists 6 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 8 Dec 2023.