Healthy SubjectsPhase 1NCT06308523
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants
A Phase 1 study testing AP303 150 μg and AP303 300 μg in people with Healthy Subjects, run by Alebund Pharmaceuticals at 1 site in China.
Trial summary
The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AP303 150 μg and AP303 300 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 13 May 2024
- 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
Important Inclusion Criteria:
- Healthy male and female participants, 18-50 years of age.
- BMI (body mass index) 18-27 kg/m2.
Important Exclusion criteria:
- History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological disease or cancer.
- Personal history of congenital long QT syndrome or family history of sudden death.
- People with a history of specific severe allergies, or severe allergic conditions or known allergies to the study or any of its ingredients or excipients as judged by the investigator, or any acute confirmed significant allergic reactions to any drug, or multiple drug severe allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
- History of having received or currently receiving any systemic anti-neoplastic or immunomodulatory treatment (including systemic oral or inhaled corticosteroids) ≤6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Participants who have had significant acute infection, e.g., COVID-19, influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks before study drug administration.
- Confirmed systolic BP greater than 140 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
- Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG.
- Implantation of cardiac pacemaker or clinically significant arrhythmias.
- Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 (using the CKD-EPI equation).
- Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb), human immunodeficiency virus (HIV Ab) or syphilis AB.
- ALT or AST >1.5 × ULN, or any other clinically significant abnormalities in laboratory test results at screening.
- Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives whichever is the longer) prior to first dose of this study.
- Donation of component (plasma or platelet) or whole blood ≥200 mL within 4 weeks prior to screening.
- Receipt of a live vaccine within 4 weeks of prior to screening (Influenza and COVID-19 vaccines are allowed).
- Positive urine test for drugs of abus.
- History of drug and/or alcohol abuse or addiction.
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption within 48 hours before screening.
- Use of >5 cigarettes or equivalent nicotine-containing product per day.
- Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 30 days or 5 half-lives (whichever is the longer) of the first dose of study drug. Occasional paracetamol is allowed (see section on Permitted Therapy). Exceptions may be made on a case-by-case basis following discussion and agreement between the investigator and the sponsor.
- Medical or social conditions that would potentially interfere with the participant's ability to comply with the study visit schedule or the study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Healthy Chinese Participants.
The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.
Read the detailed description
Eligible study participants will be enrolled and randomized into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at 2:1 ratio (6 on AP303 and 3 on placebo).
- Conditions
- Healthy Subjects
- Being tested
- AP303 150 μg, Placebo 150 μg, AP303 300 μg, Placebo 300 μg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP303 150 μgDrug
AP303 Tablet 150 μg QD
Placebo 150 μgDrug
Placebo Tablet 150 μg QD
AP303 300 μgDrug
AP303 Tablet 300 μg QD
Placebo 300 μgDrug
Placebo Tablet 300 μg QD
| Study group | Role | What they receive |
|---|---|---|
| AP303 | Experimental | Not described Receives: Drug: AP303 150 μg; Drug: AP303 300 μg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo 150 μg; Drug: Placebo 300 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: Day 1, Day 3-14
Tmax
Time to maximum observed plasma concentration
Measured: Day 1, Day 3-14
AUC0-24h
Area under the plasma concentration versus time curve up to 24 hours
Measured: Day 1
AUC0-last
Area under the plasma concentration versus time curve up to the last measurable concentration
Measured: Day 1
AUC0-inf
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Day 1
AUC0-t
Area under the plasma concentration-time curve for a dosing interval
Measured: Day 3-14
t1/2
Apparent terminal half-life, computed as ln(2)/λz
Measured: Day 1, Day 3-14
CL/F
Apparent oral clearance calculated from Dose/ AUC0-inf
Measured: Day 1
V/F
Apparent volume of distribution of oral drug
Measured: Day 1, Day 3-14
Cav
average plasma concentration
Measured: Day 3-14
Ctrough
Trough plasma concentration
Measured: Day 3-14
Rac
Ratio of accumulation
Measured: Day 3-14
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Day 1-28
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Measured: Day 1-28
Effect of AP303 on ECG parameters
Heart rate in beats/min
Measured: Day 1-28
Effect of AP303 on ECG parameters
QT in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
PR in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
QRS in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
QTcF in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
QTcB in ms
Measured: Day 1-28
Vital signs
Effect of AP303 on vital signs, e.g. blood pressure
Measured: Day 1-28
Effect of AP303 on physical examination result
nature, frequency, and severity of abnormality of physical examination result
Measured: Day 1-28
body weight
Effect of AP303 on body weight, e.g. change of body weight after administration of AP303
Measured: Day 1-28
Secondary outcomes (4)
Fasting glucose
Fasting glucose
Measured: Baseline, Days 5, 10, 14 and 28
Fasting lipid profile
Triglyceride, HDL-C, LDL-C, Total cholesterol
Measured: Baseline, Days 5, 10, 14 and 28
Serum creatinine
Serum creatinine
Measured: Baseline, Days 5, 10, 14 and 28
eGFR
Estimated glomerular filtration rate
Measured: Baseline, Days 5, 10, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start18 Mar 2024
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alebund Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308523
- Sponsor's protocol ID
- AP303-PK-02
- Status last verified
- Oct 2024
- First submitted
- 20 Feb 2024
- Last updated
- 22 Oct 2024
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Healthy Chinese Participants.
- ClinicalTrials.gov ID
- NCT06308523
- Acronym / sponsor ID
- AP303-PK-02
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alebund PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 13 Mar 2024 (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 study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.
Detailed description
Eligible study participants will be enrolled and randomized into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at 2:1 ratio (6 on AP303 and 3 on placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP303 | Experimental | Drug: AP303 150 μg, Drug: AP303 300 μg |
| Placebo | Placebo comparator | Drug: Placebo 150 μg, Drug: Placebo 300 μg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| AP303 150 μgAP303 Tablet 150 μg QD | Drug | AP303 |
| Placebo 150 μgPlacebo Tablet 150 μg QD | Drug | Placebo |
| AP303 300 μgAP303 Tablet 300 μg QD | Drug | AP303 |
| Placebo 300 μgPlacebo Tablet 300 μg QD | Drug | Placebo |
Primary outcome
Cmax
Time frame: Day 1, Day 3-14
Maximum observed plasma concentration
Tmax
Time frame: Day 1, Day 3-14
Time to maximum observed plasma concentration
AUC0-24h
Time frame: Day 1
Area under the plasma concentration versus time curve up to 24 hours
AUC0-last
Time frame: Day 1
Area under the plasma concentration versus time curve up to the last measurable concentration
AUC0-inf
Time frame: Day 1
Area under the plasma concentration versus time curve extrapolated to infinity
AUC0-t
Time frame: Day 3-14
Area under the plasma concentration-time curve for a dosing interval
t1/2
Time frame: Day 1, Day 3-14
Apparent terminal half-life, computed as ln(2)/λz
CL/F
Time frame: Day 1
Apparent oral clearance calculated from Dose/ AUC0-inf
V/F
Time frame: Day 1, Day 3-14
Apparent volume of distribution of oral drug
Cav
Time frame: Day 3-14
average plasma concentration
Ctrough
Time frame: Day 3-14
Trough plasma concentration
Rac
Time frame: Day 3-14
Ratio of accumulation
Incidence and severity of adverse events
Time frame: Day 1-28
Incidence and severity of adverse events
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Time frame: Day 1-28
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Heart rate in beats/min
Effect of AP303 on ECG parameters
Time frame: Day 1-28
QT in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
PR in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
QRS in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
QTcF in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
QTcB in ms
Vital signs
Time frame: Day 1-28
Effect of AP303 on vital signs, e.g. blood pressure
Effect of AP303 on physical examination result
Time frame: Day 1-28
nature, frequency, and severity of abnormality of physical examination result
body weight
Time frame: Day 1-28
Effect of AP303 on body weight, e.g. change of body weight after administration of AP303
4 secondary outcomes
Fasting glucose
Time frame: Baseline, Days 5, 10, 14 and 28
Fasting lipid profile
Time frame: Baseline, Days 5, 10, 14 and 28
Serum creatinine
Time frame: Baseline, Days 5, 10, 14 and 28
eGFR
Time frame: Baseline, Days 5, 10, 14 and 28
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 22 Oct 2024.
- 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 AP303 150 μg and AP303 300 μg in people with Healthy Subjects, run by Alebund Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Oct 2024. 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 China. 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?
Cmax (time frame: Day 1, Day 3-14). The study lists 23 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 Oct 2024.