Clinical trial NCT05712876: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interleukin-22
Safety
Tolerability
Pharmacokinetics
Lead sponsor: Cytoki Pharma
Sponsor class: INDUSTRY
Collaborators: name: SGS Life Sciences, a division of SGS Belgium NV
First posted: 2023-02-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence, severity and seriousness of treatment emergent adverse events
timeFrame: Up to 8 weeks after last dose
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 to 8 weeks after last dose
measure: Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration
timeFrame: Day 1 to Day 8
measure: Area under the serum concentration-time curve from 0 to infinity (AUCinf)
timeFrame: Day 1 to 8 weeks after last dose
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Clinical Research, Clinical Pharmacology Unit
Study officials:
affiliation: Cytoki Pharma
name: Anne Louise Kjølbye, PhD
role: STUDY_DIRECTOR
affiliation: SGS Clinical Research, Clinical Pharmacology Unit
name: Lotte Verwillingen, MD
role: PRINCIPAL_INVESTIGATOR
References: