HealthyPhase 1NCT06030375
Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567
A Phase 1 study testing KAND567 in people with Healthy, run by Novakand Pharma AB at 1 site in Finland.
Trial summary
The study was planned to consist of 24 healthy subjects in 3 dosing cohorts receiving a continuous i.v. infusion of KAND567 or placebo for 6 h (6 subjects on active and 2 subjects on placebo per cohort), with the option of two additional cohorts of the same size and group composition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KAND567
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- 17 Feb 2020to 27 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent prior to any study specific procedures
- Body weight > 50 kg
- Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m^2 at screening
- Healthy male and female subjects aged ≥ 18 and ≤ 65 years at screening
- Male subjects must agree to use an adequate method of contraception. Male subjects who are heterosexually active must use, with their partner, a condom AND one of the following methods of highly effective contraception from the time of IMP administration until 90 days after dosing of IMP.
- oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable or implanted hormonal contraceptives
Show all 12Show fewer
- intrauterine device
- intrauterine system (for example progestin-releasing coil)
- vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- bilateral tubal occlusion or hysterectomy
- Female subject must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months' amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone 25-140 IE/L and estradiol < 200 pmol/L is confirmatory])
- Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements
Who cannot join
- Present or known history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental, metabolic, endocrine, haematological, gastrointestinal disorder, significant respiratory disease, sleep apnoea, narcolepsy or any other major disorder that may interfere with the objectives of the study, as judged by the investigator
- Any clinically significant abnormalities in physical examination, electrocardiogram (ECG; e.g. QTcF>450 ms), clinical chemistry, haematology or urinalysis results at screening, as judged by the investigator
- Clinically significant abnormal blood pressure (treated or untreated), defined as systolic pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 90 mmHg at screening
- Pulse rate < 45 bpm at screening
- Clinically significant illness within the 5 days prior to the administration of the IMP
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV)
Show all 16Show fewer
- Known or suspected drug or alcohol abuse or positive screen for drugs of abuse test or positive alcohol breath test at screening visit or any time prior to randomisation
- Smoking > 5 cigarettes per day, or inability to refrain from smoking or using other nicotine-containing products during the stay at the study centre.
- Subject who has received any investigational drug within the last 3 months before administration of IMP
- Plasma donation within one month of screening visit, or any blood donation/ blood loss > 450 mL during the 3 months prior to screening visit
- Use of the herbal remedy St. John's Wort within two weeks prior to the first dose of the IMP (induces cytochrome P450-3A4)
- Use of prescribed medication during the two weeks prior to the administration of the IMP (or longer if the prescribed medication has a half-life long enough to potentially expose the subject to any significant systemic exposure, as judged by the investigator)
- Use of over-the-counter drugs (including herbals (St. John's Wort - see above), vitamins and minerals) during one week prior to the administration of the IMP or need for concomitant medication during the study. However, occasional paracetamol for pain relief is allowed (up to 3 g per 24 hours)
- Female subjects: Positive pregnancy test at screening visit or at any time prior to randomisation
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
- Subject has an eGFR < 80 mL/min/1.73m^2 at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567. A Single-centre, Placebo-controlled, Randomised, Double-blind Study in Healthy Subjects
The study was planned to consist of 24 healthy subjects in 3 dosing cohorts receiving a continuous i.v. infusion of KAND567 or placebo for 6 h (6 subjects on active and 2 subjects on placebo per cohort), with the option of two additional cohorts of the same size and group composition.
Read the detailed description
The 3 planned dose levels of KAND567 were based on preliminary data from previous i.v. infusions and were chosen to obtain approximate Css levels of 0.5, 1.0 and 2.0 μM. The dose levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3).
Each cohort of participants was planned to consist of 8 subjects (2 on placebo and 6 on active drug), i.e. a total of 24 subjects. A sentinel approach was used for all three cohorts, starting dosing with two subjects (one on active drug, one on placebo). If safe and tolerable, an additional two or three subjects will be administered. If safe and tolerable, the remaining three or four subjects of the cohort were dosed. There was an evaluation of safety and tolerability from the previous cohort prior to proceeding to the next cohort.
- Conditions
- Healthy
- Being tested
- KAND567, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAND567Drug
Continuous intravenous infusion for 6 hours
PlaceboOther
Continuous intravenous infusion for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| KAND567 in ascending doses | Active comparator | In each of the 3 cohorts, 6 subjects were planned to be randomised to receive KAND567. The dose levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3). Receives: Drug: KAND567 |
| Placebo | Placebo comparator | In each of the 3 cohorts, 2 subjects were planned to be randomised to receive Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after continuous infusion of KAND567, as measured by adverse events (AEs)
Measured by the occurrence of AEs and serious adverse events (SAEs)
Measured: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by vital signs
Measured by the occurrence of clinically abnormal vital signs
Measured: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by ECG
Measured by the occurrence of clinically abnormal electrocardiography (ECG)
Measured: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Safety and tolerability after continuous infusion of KAND567, as measured by lab safety tests
Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology, and urinalysis)
Measured: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Css
Measured by plasma drug concentration at steady state (Css)
Measured: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by AUC
Measured by the area under the plasma concentration-time curve (AUC)
Measured: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by t1/2z
Measured by terminal half-life (t1/2z)
Measured: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Vss
Measured by the apparent volume of distribution at steady state (Vss)
Measured: From the first IMP administration (Day 1) until Day 2
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by CL
Measured by the systemic clearance (CL)
Measured: From the first IMP administration (Day 1) until Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start17 Feb 2020
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novakand Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mika Scheinin, MD, PhD, Principal investigator, Clinical Research Services Turku (CRST)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030375
- Sponsor's protocol ID
- KAN0004
- Other IDs
- 2019-004585-18, 2019
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2023
- Last updated
- 11 Sep 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567. A Single-centre, Placebo-controlled, Randomised, Double-blind Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06030375
- Acronym / sponsor ID
- KAN0004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novakand Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 11 Sep 2023 (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 was planned to consist of 24 healthy subjects in 3 dosing cohorts receiving a continuous i.v. infusion of KAND567 or placebo for 6 h (6 subjects on active and 2 subjects on placebo per cohort), with the option of two additional cohorts of the same size and group composition.
Detailed description
The 3 planned dose levels of KAND567 were based on preliminary data from previous i.v. infusions and were chosen to obtain approximate Css levels of 0.5, 1.0 and 2.0 μM. The dose levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3).
Each cohort of participants was planned to consist of 8 subjects (2 on placebo and 6 on active drug), i.e. a total of 24 subjects. A sentinel approach was used for all three cohorts, starting dosing with two subjects (one on active drug, one on placebo). If safe and tolerable, an additional two or three subjects will be administered. If safe and tolerable, the remaining three or four subjects of the cohort were dosed. There was an evaluation of safety and tolerability from the previous cohort prior to proceeding to the next cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAND567 in ascending doses | Active comparator | Drug: KAND567In each of the 3 cohorts, 6 subjects were planned to be randomised to receive KAND567. The dose levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3). |
| Placebo | Placebo comparator | Other: PlaceboIn each of the 3 cohorts, 2 subjects were planned to be randomised to receive Placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of written informed consent prior to any study specific procedures
- Body weight > 50 kg
- Body Mass Index (BMI) ≥ 19 and ≤ 30 kg/m^2 at screening
- Healthy male and female subjects aged ≥ 18 and ≤ 65 years at screening
- Male subjects must agree to use an adequate method of contraception. Male subjects who are heterosexually active must use, with their partner, a condom AND one of the following methods of highly effective contraception from the time of IMP administration until 90 days after dosing of IMP.
Key exclusion criteria (16 listed)
- Present or known history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental, metabolic, endocrine, haematological, gastrointestinal disorder, significant respiratory disease, sleep apnoea, narcolepsy or any other major disorder that may interfere with the objectives of the study, as judged by the investigator
- Any clinically significant abnormalities in physical examination, electrocardiogram (ECG; e.g. QTcF>450 ms), clinical chemistry, haematology or urinalysis results at screening, as judged by the investigator
- Clinically significant abnormal blood pressure (treated or untreated), defined as systolic pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 90 mmHg at screening
- Pulse rate < 45 bpm at screening
- Clinically significant illness within the 5 days prior to the administration of the IMP
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 |
|---|---|---|
| KAND567Continuous intravenous infusion for 6 hours | Drug | KAND567 in ascending doses |
| PlaceboContinuous intravenous infusion for 6 hours | Other | Placebo |
Primary outcome
Safety and tolerability after continuous infusion of KAND567, as measured by adverse events (AEs)
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Measured by the occurrence of AEs and serious adverse events (SAEs)
Safety and tolerability after continuous infusion of KAND567, as measured by vital signs
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Measured by the occurrence of clinically abnormal vital signs
Safety and tolerability after continuous infusion of KAND567, as measured by ECG
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Measured by the occurrence of clinically abnormal electrocardiography (ECG)
Safety and tolerability after continuous infusion of KAND567, as measured by lab safety tests
Time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)
Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology, and urinalysis)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Css
Time frame: From the first IMP administration (Day 1) until Day 2
Measured by plasma drug concentration at steady state (Css)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by AUC
Time frame: From the first IMP administration (Day 1) until Day 2
Measured by the area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by t1/2z
Time frame: From the first IMP administration (Day 1) until Day 2
Measured by terminal half-life (t1/2z)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by Vss
Time frame: From the first IMP administration (Day 1) until Day 2
Measured by the apparent volume of distribution at steady state (Vss)
Pharmacokinetics (PK) after continuous infusion of KAND567, as measured by CL
Time frame: From the first IMP administration (Day 1) until Day 2
Measured by the systemic clearance (CL)
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 11 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Mika Scheinin, MD, PhD principal investigator
Clinical Research Services Turku (CRST)
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 KAND567 in people with Healthy, run by Novakand Pharma AB at 1 site in Finland.
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 12 inclusion and 16 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 11 Sep 2023. 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 Finland. 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 and tolerability after continuous infusion of KAND567, as measured by adverse events (AEs) (time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 30)). The study lists 9 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 11 Sep 2023.