A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity

January 9, 2024 updated by: Cytoki Pharma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • SGS Clinical Research, Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single ascending dose (SAD) CK-0045 Dose level 1 to 5
At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration
Drug: CK-0045
Interleukin-22 agonist
Placebo Comparator: SAD placebo
At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration
Drug: Placebo
Matching placebo
Placebo Comparator: MAD placebo
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
Drug: Placebo
Matching placebo
Experimental: Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3
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
Drug: CK-0045
Interleukin-22 agonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 8 weeks after last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration
Time Frame: Day 1 to Day 8
AUC168 following single and multiple ascending doses of CK-0045 will be characterized
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
AUCinf following single and multiple ascending doses of CK-0045 will be characterized
Day 1 to 8 weeks after last dose
Maximum observed concentration (Cmax)
Time Frame: Day 1 to 8 weeks after last dose
The Cmax following single and multiple ascending doses of CK-0045 will be characterized
Day 1 to 8 weeks after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cytoki Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SGS Life Sciences, a division of SGS Belgium NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne Louise Kjølbye, PhD, Cytoki Pharma
  • Principal Investigator: Lotte Verwillingen, MD, SGS Clinical Research, Clinical Pharmacology Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CK-0045_CS01
  • 2022-002994-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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