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
Overview
- Phase
- Phase 1
- Intervention
- CK-0045
- Conditions
- Healthy
- Sponsor
- Cytoki Pharma
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Incidence, severity and seriousness of treatment emergent adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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 -
- •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 -
- •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.
Arms & Interventions
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
Intervention: CK-0045
SAD placebo
At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration
Intervention: Placebo
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
Intervention: CK-0045
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
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence, severity and seriousness of treatment emergent adverse events
Time Frame: Up to 8 weeks after last dose
The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
Secondary Outcomes
- 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)