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

NCT05712876 | Completed Phase 1

• 2 other identifiers: CK-0045_CS012022-002994-27
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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. 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

Keywords

Interleukin-22; Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum observed concentration (Cmax)

  Day 1 to 8 weeks after last dose

• Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration

  Day 1 to Day 8

• Area under the serum concentration-time curve from 0 to infinity (AUCinf)

  Day 1 to 8 weeks after last dose

Study Arms (4)

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

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

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

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

Drug: Placebo

Interventions

CK-0045 DRUG

Interleukin-22 agonist

Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3; Single ascending dose (SAD) CK-0045 Dose level 1 to 5

Placebo DRUG

Matching placebo

MAD placebo; SAD placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytoki Pharma: lead
• SGS Life Sciences, a division of SGS Belgium NV: collaborator

Study Sites (1)

SGS Clinical Research, Clinical Pharmacology Unit

Edegem, 2650, Belgium

Location

Study Officials

• Anne Louise Kjølbye, PhD

  Cytoki Pharma

  STUDY DIRECTOR

• Lotte Verwillingen, MD

  SGS Clinical Research, Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 6, 2023
• Study Start: December 26, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)