a phase 1 study to investigate safety, tolerability, and pharmacokinetics of ck-0045 in healthy participants and otherwise healthy participants with obesity

Conditions: Healthy

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.

Keywords: interleukin-22 safety tolerability pharmacokinetics