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

Primary Purpose

Healthy

Status
Recruiting
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
CK-0045
Placebo
Sponsored by
Cytoki Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Interleukin-22, Safety, Tolerability, Pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SGS Clinical Research, Clinical Pharmacology UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Single ascending dose (SAD) CK-0045 Dose level 1 to 5

SAD placebo

Multiple ascending dose (MAD) CK-0045 Dose level 1 to 4

MAD placebo

Arm Description

At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration

At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum observed concentration (Cmax)
The Cmax following single and multiple ascending doses of CK-0045 will be characterized
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
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

Full Information

First Posted
January 16, 2023
Last Updated
June 20, 2023
Sponsor
Cytoki Pharma
Collaborators
SGS Life Sciences, a division of SGS Belgium NV
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1. Study Identification

Unique Protocol Identification Number
NCT05712876
Brief Title
A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytoki Pharma
Collaborators
SGS Life Sciences, a division of SGS Belgium NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. A maximum of 88 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: Up to 40 healthy participants will receive a single dose and up to 48 otherwise healthy participants with obesity will receive 6 doses one week apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Interleukin-22, Safety, Tolerability, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single ascending dose (SAD) CK-0045 Dose level 1 to 5
Arm Type
Experimental
Arm Description
At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration
Arm Title
SAD placebo
Arm Type
Placebo Comparator
Arm Description
At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration
Arm Title
Multiple ascending dose (MAD) CK-0045 Dose level 1 to 4
Arm Type
Experimental
Arm Description
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
Arm Title
MAD placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CK-0045
Intervention Description
Interleukin-22 agonist
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence, severity and seriousness of treatment emergent adverse events
Description
The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
Time Frame
Up to 8 weeks after last dose
Secondary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Description
The Cmax following single and multiple ascending doses of CK-0045 will be characterized
Time Frame
Day 1 to 8 weeks after last dose
Title
Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration
Description
AUC168 following single and multiple ascending doses of CK-0045 will be characterized
Time Frame
Day 1 to Day 8
Title
Area under the serum concentration-time curve from 0 to infinity (AUCinf)
Description
AUCinf following single and multiple ascending doses of CK-0045 will be characterized
Time Frame
Day 1 to 8 weeks after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Louise Kjølbye, PhD
Phone
+4530451043
Email
alk@cytokipharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Louise Kjølbye, PhD
Organizational Affiliation
Cytoki Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lotte Verwillingen, MD
Organizational Affiliation
SGS Clinical Research, Clinical Pharmacology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS Clinical Research, Clinical Pharmacology Unit
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotte Verwillingen, MD
Phone
+32 (0)3 217 25 60
Email
Lotte.Verwillingen@sgs.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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