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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: CK-0045

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	Up to 8 weeks after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1 to 8 weeks after last dose
Maximum observed concentration (Cmax)	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

• Sponsor: Cytoki Pharma
• Collaborators: SGS Life Sciences, a division of SGS Belgium NV
• Investigators: Study Director: Anne Louise Kjølbye, PhD, Cytoki Pharma; Principal Investigator: Lotte Verwillingen, MD, SGS Clinical Research, Clinical Pharmacology Unit

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Interleukin-22
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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