NCT05712876已完成1 期
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
Cytoki Pharma1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年12月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Incidence, severity and seriousness of treatment emergent adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 -
- •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.
研究组 & 干预措施
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
干预措施: CK-0045 (Drug)
SAD placebo
Placebo Comparator
At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration
干预措施: Placebo (Drug)
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
干预措施: CK-0045 (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity and seriousness of treatment emergent adverse events
时间窗: Up to 8 weeks after last dose
The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed
次要结局
- 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)
研究者
研究点 (1)
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