Immune System DiseasesPhase 1NCT04449939
A Study of Subcutaneous KY1005 in Healthy Volunteers
A Phase 1 study testing KY1005 in people with Immune System Diseases, run by Kymab Limited at 1 site in United Kingdom.
Trial summary
Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases
- What is being tested?
- KY1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2020to 30 Nov 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 18-45 years at screening
- Body weight 60-120 kg
- Body mass index (BMI) in the range 18.0-30.0 kg/m^2 (inclusive)
- Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine
Who cannot join
- Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
- Drug or alcohol abuse
- Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
- Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study
- Loss of more than 400 mL blood, within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers
Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.
- Conditions
- Immune System Diseases
- Being tested
- KY1005
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KY1005Drug
A human anti-OX40 ligand monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Single dose of KY1005 by i.v. infusion Receives: Drug: KY1005 |
| Group 2 | Experimental | Single lower dose KY1005 by s.c. injection Receives: Drug: KY1005 |
| Group 3 | Experimental | Single higher dose KY1005 by s.c. injections Receives: Drug: KY1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) after infusion
Measured: Baseline to day 92
Time at which Cmax is observed after infusion (tmax)
Measured: Baseline to day 92
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Measured: Baseline to day 92
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Measured: Baseline to day 92
Systemic clearance after i.v. infusion (CL)
Measured: Baseline to day 92
Apparent systemic clearance after s.c. injection (CL/F)
Measured: Baseline to day 92
Volume of distribution during the terminal phase after i.v. infusion (Vz)
Measured: Baseline to day 92
Apparent volume of distribution after s.c. injection (Vz/F)
Measured: Baseline to day 92
Steady-state volume of distribution after i.v. infusion (Vss)
Measured: Baseline to day 92
Weight-normalised Vss and Vz
Measured: Baseline to day 92
Half-life t½
Measured: Baseline to day 92
Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration
Measured: Baseline to day 92
Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion
Measured: Baseline to day 92
Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration
Measured: Baseline to day 92
Secondary outcomes (8)
Occurrence of TEAE
Measured: Baseline to day 92
Occurrence of TESAE
Measured: Baseline to day 92
Occurrence of local injection site reactions
Measured: Baseline to day 92
Changes in blood pressure mmHg (as a measure of safety and tolerability)
Measured: Baseline to day 92
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)
Measured: Baseline to day 92
Changes in heart rate bpm (as a measure of safety and tolerability)
Measured: Baseline to day 92
Changes in tympanic temperature °C (as a measure of safety and tolerability)
Measured: Baseline to day 92
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)
Measured: Baseline to day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start7 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, MBBS JCPTGP MPhil, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449939
- Sponsor's protocol ID
- KY1005-CT04
- Status last verified
- Sep 2021
- First submitted
- 15 Jun 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04449939
- Acronym / sponsor ID
- KY1005-CT04
- Conditions
- Immune System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kymab LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 29 Jun 2020 (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.
Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: KY1005Single dose of KY1005 by i.v. infusion |
| Group 2 | Experimental | Drug: KY1005Single lower dose KY1005 by s.c. injection |
| Group 3 | Experimental | Drug: KY1005Single higher dose KY1005 by s.c. injections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male, aged 18-45 years at screening
- Body weight 60-120 kg
- Body mass index (BMI) in the range 18.0-30.0 kg/m^2 (inclusive)
- Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine
Key exclusion criteria (5 listed)
- Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
- Drug or alcohol abuse
- Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
- Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study
- Loss of more than 400 mL blood, within the previous 3 months
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 |
|---|---|---|
| KY1005A human anti-OX40 ligand monoclonal antibody | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Maximum observed concentration (Cmax) after infusion
Time frame: Baseline to day 92
Time at which Cmax is observed after infusion (tmax)
Time frame: Baseline to day 92
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Time frame: Baseline to day 92
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Time frame: Baseline to day 92
Systemic clearance after i.v. infusion (CL)
Time frame: Baseline to day 92
Apparent systemic clearance after s.c. injection (CL/F)
Time frame: Baseline to day 92
Volume of distribution during the terminal phase after i.v. infusion (Vz)
Time frame: Baseline to day 92
Apparent volume of distribution after s.c. injection (Vz/F)
Time frame: Baseline to day 92
Steady-state volume of distribution after i.v. infusion (Vss)
Time frame: Baseline to day 92
Weight-normalised Vss and Vz
Time frame: Baseline to day 92
Half-life t½
Time frame: Baseline to day 92
Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration
Time frame: Baseline to day 92
Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion
Time frame: Baseline to day 92
Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration
Time frame: Baseline to day 92
8 secondary outcomes
Occurrence of TEAE
Time frame: Baseline to day 92
Occurrence of TESAE
Time frame: Baseline to day 92
Occurrence of local injection site reactions
Time frame: Baseline to day 92
Changes in blood pressure mmHg (as a measure of safety and tolerability)
Time frame: Baseline to day 92
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)
Time frame: Baseline to day 92
Changes in heart rate bpm (as a measure of safety and tolerability)
Time frame: Baseline to day 92
Changes in tympanic temperature °C (as a measure of safety and tolerability)
Time frame: Baseline to day 92
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)
Time frame: Baseline to day 92
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 30 Sep 2021.
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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.
Adeep Puri, MBBS JCPTGP MPhil principal investigator
Hammersmith Medicines Research
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 KY1005 in people with Immune System Diseases, run by Kymab Limited 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 4 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 30 Sep 2021. 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. 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?
Maximum observed concentration (Cmax) after infusion (time frame: Baseline to day 92). The study lists 14 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 30 Sep 2021.