Healthy Adult SubjectsPhase 1NCT05223660
A Phase I Pharmacokinetics Study for KT07 Capsule
A Phase 1 study testing Low dose KT07 and High dose KT07 in people with Healthy Adult Subjects and Pharmacokinetics, run by Yiling Pharmaceutical Inc. at 1 site in United States.
Trial summary
This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects, Pharmacokinetics, Safety and Tolerability
- What is being tested?
- Low dose KT07 and High dose KT07
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 6 Sep 2022
- 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
- Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the screening procedures will be performed.
- 18 to 65 years of age, inclusive, at screening, male or female.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 at screening.
- Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
- All female subjects of child-bearing potential must have a negative serum pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g, abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 90 days after study drug discontinuation.
- Agrees to the collection of nasopharyngeal (NP) swabs for SARS-CoV-2 testing.
Who cannot join
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
- Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
- Positive SARS-CoV-2 testing by standard RT-PCR assay.
- Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
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- Positive urine test for ethanol/drug/cotinine at Screening or Day -1.
- History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week or are unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until completion of the study. Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
- History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator or are unwilling to abstain from illicit drug use consumption during the entire study. Positive drug test, including marijuana.
- Excessive consumption of coffee, tea, cola, or other caffeinated beverages; excessive consumption is defined as >6 servings per day (1 serving contains approximately 120 mg caffeine).
- Donation of blood (> 500 mL) or blood products within 2 months prior to Day -1.
- Use of over-the-counter (OTC) vitamins and medications, prescription medications, an investigational drug or herbal remedies from 14 days prior to the first dose.
- Subject has a history of hypersensitivity to the investigational product (IP) or any of the ingredient or excipient of IP.
- Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to admission.
- Subject has consumed grapefruit or grapefruit juice within the 14 days prior to admission.
- Pregnant or breast-feeding female subjects
- Previous history of difficulty swallowing capsules.
- History and/or family history of congenital long QT syndrome, unexplained syncope, or other additional risks of Torsade de Pointes or sudden premature death.
- Subject with any of the following ECG results at Screening or Admission will be excluded:
- PR interval >220 msec or <110 msec
- RR interval > 1333 msec
- QRS interval >120 msec
- QTcF >470 msec
- ST segment elevation or depression considered clinically significant by the PI or designee
- T-wave abnormalities considered to be clinically significant by the PI or designee
- An average systolic blood pressure ≥140 mmHg or ≤ 90 mmHg; an average diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg.
- Participants with history of hyperthyroidism and increased intraocular pressure.
- Glomerular filtration rate (GFR) ≤70 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.at Screening
- Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT), or alkaline phosphatase (ALP) >1.2 × upper limit of the reference range (ULRR) at Screening or Admission
- History of significant multiple and/or severe allergies (including latex allergy); anaphylactic reaction; or significant prescription drug, non-prescription drug, or food intolerance.
- Any vaccination within 7 days of Screening or any vaccination with an mRNA or adenovirus platform vaccine within 30 days of Screening
- Hemoglobin (HbA1C) > 6.5
- Any other factors that the Investigator considers not suitable for participating in this trial.
- Subject is unable to understand the protocol requirements, instructions and study related restrictions, as well as the nature, scope, and possible consequences of the clinical study.
- Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions, such as uncooperative attitude, inability to return for follow-up visits, and improbability of completing the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single-Center Study to Assess Pharmacokinetics, Safety and Tolerability of KT07 in Healthy Adult Subjects
This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2.
The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2.
The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.
Read the detailed description
This is a 2-part PK study. Each Part consists of 3 phases: a 2-week screening phase, drug administration and PK sampling phase, then a safety follow-up visit at Day 7 after the last dose. Subjects enter screening at Visit 1.
Part 1: Pilot single-dose PK Study Part 1 is an open-label study. Six (6) eligible male adult healthy volunteers aged between 18 to 65 years will receive a single oral dose of KT07 capsules on Day 1.
Part 2: Single and multiple-dose PK Study A total of 20 healthy subjects will participate in this part of the study, which consists of 2 cohorts with 10 subjects each. Subjects will receive either active treatment or placebo treatment in each cohort in a double-blind manner to evaluate PK and safety of KT07.
- Being tested
- Low dose KT07, High dose KT07, Low dose Placebo, High dose Placebo
- Keywords
- Phase I, Pharmacokinetics (PK), KT07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose KT07Drug
Also called Lianhua Qinwen
A single dose of 4 capsules, followed by multiple doses on Days 8-12
High dose KT07Drug
Also called Lianhua Qingwen
A single dose of 6 capsules, followed by multiple doses on Days 8-12
Low dose PlaceboDrug
Also called placebo
A single dose of 4 capsules, followed by multiple doses on Days 8-12
High dose PlaceboDrug
Also called placebo
A single dose of 6 capsules, followed by multiple doses on Days 8-12
| Study group | Role | What they receive |
|---|---|---|
| Low dose KT07 | Experimental | KT07 single dose (4 capsules) followed by multiple doses for 5 days (tid) Receives: Drug: Low dose KT07 |
| High dose KT07 | Experimental | KT07 single dose (6 capsules) followed by multiple doses for 5 days (tid) Receives: Drug: High dose KT07 |
| Low dose placebo | Placebo comparator | Placebo single dose (4 capsules) followed by multiple doses for 5 days (tid) Receives: Drug: Low dose Placebo |
| High dose placebo | Placebo comparator | Placebo single dose (6 capsules) followed by multiple doses for 5 days (tid) Receives: Drug: High dose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) 0-t
AUC calculation up to the last measurable concentration
Measured: 13 days
AUC0-∞
AUC calculation from time 0 to infinity
Measured: 13 days
Maximum (or peak) serum concentration (Cmax)
Assess the peak concentration of KT07
Measured: 13 days
Time to achieve maximum drug concentration (Tmax)
Assess when KT07 reach its peak concentration
Measured: 13 days
Trough concentration (Ctrough)
Assess the lowest concentration of KT07
Measured: 13 days
Time required to reduce the drug concentration to ½ of its initial value (t1/2)
Assess the half-life of KT07
Measured: 13 days
Volume of plasma cleared of drug per unit time (CL/F)
Assess the plasma clearance of KT07
Measured: 13 days
Volume of distribution at terminal phase (Vz/F)
Assess the Volume of distribution of KT07
Measured: 13 days
AUCextrap
Percentage of AUCinf-pred due to extrapolation from Tlast to infinity
Measured: 13 days
Cmax (Racc_Cmax)
Maximum concentrations anticipated at plateau
Measured: 13 days
AUC (Racc_AUCss)
Area under the curve anticipated at plateau
Measured: 13 days
Accumulation factor
Accumulation factor (R) reflects how much drug is accumulated in the body at steady state after multiple dosing as compared to that after single dosing
Measured: 13 days
Secondary outcomes (3)
Severity of adverse events
Severity assessment of adverse events using protocol-defined criteria after first dose in adult healthy subjects
Measured: 19 days
Causality of adverse events
Causality assessment of adverse events using protocol-defined criteria after first dose in adult healthy subjects
Measured: 19 days
Incidence of adverse events
Incidence of adverse events up to 19 days after first dose in adult healthy subjects
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start7 Jan 2022
- Primary completion20 Jul 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yiling Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Zhang, PhD, Study director, Yiling Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223660
- Sponsor's protocol ID
- KT07-US-03
- Status last verified
- Oct 2022
- First submitted
- 10 Dec 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-Center Study to Assess Pharmacokinetics, Safety and Tolerability of KT07 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05223660
- Acronym / sponsor ID
- KT07-US-03
- Keywords
- Phase I, Pharmacokinetics (PK), KT07
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yiling Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2.
The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2.
The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.
Detailed description
This is a 2-part PK study. Each Part consists of 3 phases: a 2-week screening phase, drug administration and PK sampling phase, then a safety follow-up visit at Day 7 after the last dose. Subjects enter screening at Visit 1.
Part 1: Pilot single-dose PK Study Part 1 is an open-label study. Six (6) eligible male adult healthy volunteers aged between 18 to 65 years will receive a single oral dose of KT07 capsules on Day 1.
Part 2: Single and multiple-dose PK Study A total of 20 healthy subjects will participate in this part of the study, which consists of 2 cohorts with 10 subjects each. Subjects will receive either active treatment or placebo treatment in each cohort in a double-blind manner to evaluate PK and safety of KT07.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose KT07 | Experimental | Drug: Low dose KT07KT07 single dose (4 capsules) followed by multiple doses for 5 days (tid) |
| High dose KT07 | Experimental | Drug: High dose KT07KT07 single dose (6 capsules) followed by multiple doses for 5 days (tid) |
| Low dose placebo | Placebo comparator | Drug: Low dose PlaceboPlacebo single dose (4 capsules) followed by multiple doses for 5 days (tid) |
| High dose placebo | Placebo comparator | Drug: High dose PlaceboPlacebo single dose (6 capsules) followed by multiple doses for 5 days (tid) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the screening procedures will be performed.
- 18 to 65 years of age, inclusive, at screening, male or female.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 at screening.
- Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
- All female subjects of child-bearing potential must have a negative serum pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g, abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 90 days after study drug discontinuation.
Key exclusion criteria (35 listed)
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
- Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
- Positive SARS-CoV-2 testing by standard RT-PCR assay.
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 |
|---|---|---|
| Low dose KT07Also: Lianhua QinwenA single dose of 4 capsules, followed by multiple doses on Days 8-12 | Drug | Low dose KT07 |
| High dose KT07Also: Lianhua QingwenA single dose of 6 capsules, followed by multiple doses on Days 8-12 | Drug | High dose KT07 |
| Low dose PlaceboAlso: placeboA single dose of 4 capsules, followed by multiple doses on Days 8-12 | Drug | Low dose placebo |
| High dose PlaceboAlso: placeboA single dose of 6 capsules, followed by multiple doses on Days 8-12 | Drug | High dose placebo |
Primary outcome
Area under the curve (AUC) 0-t
Time frame: 13 days
AUC calculation up to the last measurable concentration
AUC0-∞
Time frame: 13 days
AUC calculation from time 0 to infinity
Maximum (or peak) serum concentration (Cmax)
Time frame: 13 days
Assess the peak concentration of KT07
Time to achieve maximum drug concentration (Tmax)
Time frame: 13 days
Assess when KT07 reach its peak concentration
Trough concentration (Ctrough)
Time frame: 13 days
Assess the lowest concentration of KT07
Time required to reduce the drug concentration to ½ of its initial value (t1/2)
Time frame: 13 days
Assess the half-life of KT07
Volume of plasma cleared of drug per unit time (CL/F)
Time frame: 13 days
Assess the plasma clearance of KT07
Volume of distribution at terminal phase (Vz/F)
Time frame: 13 days
Assess the Volume of distribution of KT07
AUCextrap
Time frame: 13 days
Percentage of AUCinf-pred due to extrapolation from Tlast to infinity
Cmax (Racc_Cmax)
Time frame: 13 days
Maximum concentrations anticipated at plateau
AUC (Racc_AUCss)
Time frame: 13 days
Area under the curve anticipated at plateau
Accumulation factor
Time frame: 13 days
Accumulation factor (R) reflects how much drug is accumulated in the body at steady state after multiple dosing as compared to that after single dosing
3 secondary outcomes
Severity of adverse events
Time frame: 19 days
Causality of adverse events
Time frame: 19 days
Incidence of adverse events
Time frame: 19 days
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 17 Oct 2022.
- 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.
Nan Zhang, PhD study director
Yiling Pharmaceutical
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 Low dose KT07 and High dose KT07 in people with Healthy Adult Subjects and Pharmacokinetics, run by Yiling Pharmaceutical Inc. at 1 site in United States.
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 35 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 17 Oct 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 United States. 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?
Area under the curve (AUC) 0-t (time frame: 13 days). The study lists 12 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 17 Oct 2022.