A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity
- Registration Number
- NCT05712876
- Lead Sponsor
- Cytoki Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAD placebo Placebo At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration MAD placebo 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 Single ascending dose (SAD) CK-0045 Dose level 1 to 5 CK-0045 At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3 CK-0045 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
- Primary Outcome Measures
Name Time Method Incidence, severity and seriousness of treatment emergent adverse events Up to 8 weeks after last dose The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
- Secondary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Day 1 to 8 weeks after last dose 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 Day 1 to Day 8 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) Day 1 to 8 weeks after last dose AUCinf following single and multiple ascending doses of CK-0045 will be characterized
Trial Locations
- Locations (1)
SGS Clinical Research, Clinical Pharmacology Unit
🇧🇪Edegem, Belgium