HealthyPhase 1NCT05712876
A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity
A Phase 1 study testing CK-0045 in people with Healthy, run by Cytoki Pharma at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CK-0045
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Dec 2022to 4 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For non-vasectomized men with partners who are women of child bearing potential (WOCBP) and for WOCBP, highly effective contraception for 3 months.
- For all female participants: a negative serum (β-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1.
- In the opinion of the investigator, healthy based on medical history, physical and neurological examination, vital signs, and ECG, and clinical chemistry, hematology, coagulation, and urinalysis.
- A body weight in the range of 50 to 100 kg and a body mass index (BMI) of 18.5 to 27.0 kg/m2, inclusive, at screening for the SAD part and a BMI of 30.0 to 39.9 kg/m2, inclusive, at screening for the MAD part.
- A systolic blood pressure of ≥91 and ≤140 mmHg (SAD) / ≤145 mmHg (MAD) , a diastolic blood pressure of ≥51 and ≤80 mmHg (SAD) / ≤90 mmHg (MAD), and a pulse rate of ≥45 and ≤100 bpm at screening and Day 1 predose.
- Negative COVID-19 test (PCR) and no clinical symptoms of corona on Day -1.
- Signed informed consent form.
- Willing to adhere to the prohibitions and restrictions specified in the protocol.
Who cannot join
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant.
- Have one or more clinical laboratory test values outside the normal range at screening or on Day -1 (exceptions apply to MAD for fasting glucose, triglycerides, total cholesterol and liver enzymes).
- Has a QTcF interval >430 ms at screening or Day 1 predose for the SAD part or has a QTcF interval >450 ms (for male participants) or >470 ms (for female participants) at screening or Day 1 predose for the MAD part.
- Have a clinically significant or chronic infection or diagnosed latent infection.
- Significant acute illness within 7 days prior to the (first) study drug administration or have had a major illness or hospitalization within 1 month prior to the (first) study drug administration.
- Any history of clinically relevant skin diseases including but not limited to: Psoriasis, vitiligo, atopic dermatitis, eczema.
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- History of any malignancy.
- Tattoos present on place of injection site.
- Major or traumatic surgery within 6 months of screening.
- Any participant who plans to undergo elective surgery within 4 weeks prior to the (first) study drug administration and through the end of the study.
- Positive serology test for HIV type 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
- Recent history (within 6 months from screening) of alcohol or drug abuse.
- Active smoker and/or has used nicotine or nicotine-containing products (including e cigarettes or the equivalent of e-cigarettes) within the past 6 months of the (first) study drug administration.
- A positive urine toxicology screen at screening or Day -1 for substances of abuse.
- Have a positive alcohol breath test at screening or Day -1.
- Consumes, on average, more than approximately 500 mg/day of caffeine at screening for the SAD part or consumes, on average, more than approximately 700 mg/day of caffeine at screening for the MAD part.
- Donated blood within 90 days prior to (first) study drug administration.
- Trains/exercises intensively, e.g., for a marathon or triathlon, or at a competitive level.
- Have a history of active drug and/or food allergy or other active allergic disease requiring the constant use of medications, or a history of severe allergic reaction, angioedema or anaphylaxis at screening.
- Received any experimental therapy or new investigational agent within 30 days or 5 half-lives (whichever is longer) of the (first) study drug administration.
- Treatment with over-the-counter medications, and herbal medication within 14 days or prescription medications within 14 days or 5 half-lives (whichever is longer) prior to (first) study drug administration and through the end of the study, unless approved by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 Following Subcutaneous Administration in Healthy Participants and Otherwise Healthy Participants With Obesity
The goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. 76 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy participants will receive a single dose and 36 otherwise healthy participants with obesity will receive 6 doses one week apart.
- Conditions
- Healthy
- Being tested
- CK-0045, Placebo
- Keywords
- Interleukin-22, Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-0045Drug
Interleukin-22 agonist
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose (SAD) CK-0045 Dose level 1 to 5 | Experimental | At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration Receives: Drug: CK-0045 |
| SAD placebo | Placebo comparator | At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration Receives: Drug: Placebo |
| Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3 | Experimental | At each dose level 9 otherwise healthy participants with obesity will receive a loading dose of CK-0045 on Day 1 followed by a dose on Day 8, Day 15, Day 22, Day 29 and Day 36 of CK-0045 by s.c. administration Receives: Drug: CK-0045 |
| MAD placebo | Placebo comparator | At each dose level 3 otherwise healthy participants with obesity will receive matching placebo on Day 1, Day 8 , Day 15, Day 22, Day 29 and Day 36 by s.c. administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and seriousness of treatment emergent adverse events
The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
Measured: Up to 8 weeks after last dose
Secondary outcomes (3)
Maximum observed concentration (Cmax)
The Cmax following single and multiple ascending doses of CK-0045 will be characterized
Measured: Day 1 to 8 weeks after last dose
Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration
AUC168 following single and multiple ascending doses of CK-0045 will be characterized
Measured: Day 1 to Day 8
Area under the serum concentration-time curve from 0 to infinity (AUCinf)
AUCinf following single and multiple ascending doses of CK-0045 will be characterized
Measured: Day 1 to 8 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start26 Dec 2022
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytoki Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Responsible party
- Sponsor
- Investigators
- Anne Louise Kjølbye, PhD, Study director, Cytoki PharmaLotte Verwillingen, MD, Principal investigator, SGS Clinical Research, Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712876
- Sponsor's protocol ID
- CK-0045_CS01
- Other IDs
- 2022-002994-27
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 Following Subcutaneous Administration in Healthy Participants and Otherwise Healthy Participants With Obesity
- ClinicalTrials.gov ID
- NCT05712876
- Acronym / sponsor ID
- CK-0045_CS01
- Conditions
- Healthy
- Keywords
- Interleukin-22, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cytoki PharmaIndustry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 6 Feb 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 goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. 76 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy participants will receive a single dose and 36 otherwise healthy participants with obesity will receive 6 doses one week apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose (SAD) CK-0045 Dose level 1 to 5 | Experimental | Drug: CK-0045At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration |
| SAD placebo | Placebo comparator | Drug: PlaceboAt each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration |
| Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3 | Experimental | Drug: CK-0045At each dose level 9 otherwise healthy participants with obesity will receive a loading dose of CK-0045 on Day 1 followed by a dose on Day 8, Day 15, Day 22, Day 29 and Day 36 of CK-0045 by s.c. administration |
| MAD placebo | Placebo comparator | Drug: PlaceboAt each dose level 3 otherwise healthy participants with obesity will receive matching placebo on Day 1, Day 8 , Day 15, Day 22, Day 29 and Day 36 by s.c. administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For non-vasectomized men with partners who are women of child bearing potential (WOCBP) and for WOCBP, highly effective contraception for 3 months.
- For all female participants: a negative serum (β-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1.
- In the opinion of the investigator, healthy based on medical history, physical and neurological examination, vital signs, and ECG, and clinical chemistry, hematology, coagulation, and urinalysis.
- A body weight in the range of 50 to 100 kg and a body mass index (BMI) of 18.5 to 27.0 kg/m2, inclusive, at screening for the SAD part and a BMI of 30.0 to 39.9 kg/m2, inclusive, at screening for the MAD part.
- A systolic blood pressure of ≥91 and ≤140 mmHg (SAD) / ≤145 mmHg (MAD) , a diastolic blood pressure of ≥51 and ≤80 mmHg (SAD) / ≤90 mmHg (MAD), and a pulse rate of ≥45 and ≤100 bpm at screening and Day 1 predose.
Key exclusion criteria (21 listed)
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant.
- Have one or more clinical laboratory test values outside the normal range at screening or on Day -1 (exceptions apply to MAD for fasting glucose, triglycerides, total cholesterol and liver enzymes).
- Has a QTcF interval >430 ms at screening or Day 1 predose for the SAD part or has a QTcF interval >450 ms (for male participants) or >470 ms (for female participants) at screening or Day 1 predose for the MAD part.
- Have a clinically significant or chronic infection or diagnosed latent infection.
- Significant acute illness within 7 days prior to the (first) study drug administration or have had a major illness or hospitalization within 1 month prior to the (first) study drug administration.
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 |
|---|---|---|
| CK-0045Interleukin-22 agonist | Drug | Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3, Single ascending dose (SAD) CK-0045 Dose level 1 to 5 |
| PlaceboMatching placebo | Drug | MAD placebo, SAD placebo |
Primary outcome
Incidence, severity and seriousness of treatment emergent adverse events
Time frame: Up to 8 weeks after last dose
The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
3 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Day 1 to 8 weeks after last dose
Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration
Time frame: Day 1 to Day 8
Area under the serum concentration-time curve from 0 to infinity (AUCinf)
Time frame: Day 1 to 8 weeks after last dose
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 10 Jan 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.
Anne Louise Kjølbye, PhD study director
Cytoki Pharma
Lotte Verwillingen, MD principal investigator
SGS Clinical Research, Clinical Pharmacology 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 CK-0045 in people with Healthy, run by Cytoki Pharma at 1 site in Belgium.
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 8 inclusion and 21 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 10 Jan 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 Belgium. 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?
Incidence, severity and seriousness of treatment emergent adverse events (time frame: Up to 8 weeks after last dose). 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 10 Jan 2024.