Asthma COPDPhase 1KN-002NCT05006521
Single and Multiple Ascending Dose Study of KN-002
A Phase 1 study testing KN-002 in people with Asthma COPD, run by Kinaset Therapeutics Inc at 1 site in United Kingdom.
Trial summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma COPD
- What is being tested?
- KN-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2021to 25 Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 - 55 years old
- Willing and able to give informed consent and comply with the study
- Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
- Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
- Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4
Who cannot join
- Clinically significant laboratory test abnormalities
- Clinically significant abnormal blood pressure and/or pulse rate
- Resting ECG clinically significant abnormalities
- Respiratory tract infection within 6 weeks of screening
- Positive test for active COVID-19 within 2 days prior to administration of IMP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.
- Conditions
- Asthma COPD
- Being tested
- KN-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN-002Drug
KN-002 dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| KN-002 for SAD (Part 1) | Experimental | Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 Receives: Drug: KN-002 |
| Placebo for SAD (Part 1) | Placebo comparator | Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo Receives: Drug: KN-002 |
| KN-002 for MAD (Part 2) | Experimental | Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 Receives: Drug: KN-002 |
| Placebo for MAD (Part 2) | Experimental | Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo Receives: Drug: KN-002 |
| KN-002 for Part 3 | Experimental | Single cohort with up to 18 of 24 subjects randomised to active treatment Receives: Drug: KN-002 |
| Placebo for Part 3 | Experimental | Single cohort with up to 6 of 24 subjects randomised to placebo treatment Receives: Drug: KN-002 |
| KN-002 for Part 4 | Experimental | Single cohort with up to 18 of 24 subjects randomised to active treatment Receives: Drug: KN-002 |
| Placebo for Part 4 | Experimental | Single cohort with up to 6 of 24 subjects randomised to placebo treatment Receives: Drug: KN-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD
Measured: Day 1 to 17
Secondary outcomes (3)
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Measured: Day 1 to 17
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Measured: Day 1 to 17
Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels
Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD
Measured: Day 1 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start30 Jul 2021
- Primary completion20 Dec 2023
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma COPDStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinaset Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006521
- Sponsor's protocol ID
- KN-002/1/001
- Acronym
- KN-002
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Kinaset Therapeutics Inc. will not disclose individual subject de-identified study data
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD
- ClinicalTrials.gov ID
- NCT05006521
- Acronym / sponsor ID
- KN-002 / KN-002/1/001
- Conditions
- Asthma COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Kinaset Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 16 Aug 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 a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| KN-002 for SAD (Part 1) | Experimental | Drug: KN-002Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 |
| Placebo for SAD (Part 1) | Placebo comparator | Drug: KN-002Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo |
| KN-002 for MAD (Part 2) | Experimental | Drug: KN-002Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 |
| Placebo for MAD (Part 2) | Experimental | Drug: KN-002Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo |
| KN-002 for Part 3 | Experimental | Drug: KN-002Single cohort with up to 18 of 24 subjects randomised to active treatment |
| Placebo for Part 3 | Experimental | Drug: KN-002Single cohort with up to 6 of 24 subjects randomised to placebo treatment |
| KN-002 for Part 4 | Experimental | Drug: KN-002Single cohort with up to 18 of 24 subjects randomised to active treatment |
| Placebo for Part 4 | Experimental | Drug: KN-002Single cohort with up to 6 of 24 subjects randomised to placebo treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18 - 55 years old
- Willing and able to give informed consent and comply with the study
- Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
Key exclusion criteria (5 listed)
- Clinically significant laboratory test abnormalities
- Clinically significant abnormal blood pressure and/or pulse rate
- Resting ECG clinically significant abnormalities
- Respiratory tract infection within 6 weeks of screening
- Positive test for active COVID-19 within 2 days prior to administration of 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 |
|---|---|---|
| KN-002KN-002 dry powder inhaler | Drug | KN-002 for MAD (Part 2), KN-002 for Part 3, KN-002 for Part 4, KN-002 for SAD (Part 1), Placebo for MAD (Part 2), Placebo for Part 3, Placebo for Part 4, Placebo for SAD (Part 1) |
Primary outcome
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
Time frame: Day 1 to 17
To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD
3 secondary outcomes
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)
Time frame: Day 1 to 17
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)
Time frame: Day 1 to 17
Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels
Time frame: Day 1 to 17
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 7 Aug 2024.
- Individual participant dataSharing planned: No. Kinaset Therapeutics Inc. will not disclose individual subject de-identified study data
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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.
Dave Singh principal investigator
Medicines Evaluation Unit
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 KN-002 in people with Asthma COPD, run by Kinaset Therapeutics Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 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 7 Aug 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 United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events (time frame: Day 1 to 17). 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 7 Aug 2024.