A randomized, participant and investigator-blinded, placebo-controlled, single ascending intravenous and single subcutaneous dose study to assess the safety, tolerability and pharmacokinetics of CMK389 in Japanese healthy participants
- Conditions
- Japanese healthy participants
- Registration Number
- JPRN-jRCT2071210115
- Lead Sponsor
- Yamada Hiroyuki
- Brief Summary
Treatment with single ascending dose of i.v. CMK389 at doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg and a single s.c. CMK389 at a dose of 300 mg was safe and well tolerated in Japanese healthy participants. CMK389 showed dose-proportional increases in exposure (Cmax and AUC) with increasing dose, and constant clearance irrespective of dose with i.v. administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
1. Written informed consent must be obtained before any assessment is performed.
2. Japanese healthy participants 20 to 65 years of age included, and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening and baseline.
3. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
4. Participants must weigh at least 45 kg (female) or 50 kg (male) to participate in the study, and must have a BMI within the range of 18-30 kg/m2 at screening.
5. At screening and baseline, vital signs (body temperature, systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the participant has rested at least 3 minutes. Sitting vital signs should be within the following ranges:
- Axillary body temperature between 35.0-37.5 degree Celsius
- Systolic blood pressure, 90-139 mm Hg
- Diastolic blood pressure, 40-89 mm Hg
- Pulse rate, 40-90 bpm
1. Participants who are not capable of giving consent, persons depending on the sponsor, investigator or site as well as persons who have been committed to an institution by way of official or judicial order.
2. Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
3. Use of other investigational drugs at the time of screening, or within a period corresponding to less than 5 half-lives of the drug before screening, or within 30 days, whichever is longer.
4. Significant illness, including infectious diseases that has not resolved within 2 weeks prior to baseline, or positive SARS-CoV-2 test result at screening, or contact with a known case of COVID-19 infection in the 2 weeks prior to baseline.
5. COVID-19 vaccination in progress (plan to receive or in between the first and second dose) at baseline, or within 3 weeks of the last dose (i.e. completion of the vaccination).
6. Receipt of live/attenuated vaccine within a 1 month period before dose of CMK389 (Day 1).
7. History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg) test at screening excludes a participant. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.
8. History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (antibodies to HIV Type 1 and/or Type 2 and confirmatory test) test result at screening
9. A positive syphilis test result at Screening.
10. Any clinically relevant abnormalities on hematology and clinical chemistry at screening or baseline.
11. Any history or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (e.g., immunosuppressive treatment)
12. Any history of drug or alcohol abuse or history of recreational cannabis use within 4 weeks prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening.
13. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
14. Lifetime history of hypersensitivity or allergy to any of the study treatments or excipients or to drugs of similar chemical classes.
15. Smokers (use of tobacco/nicotine products within 3 months of dosing). Urine cotinine levels will be measured during screening and at baseline for all participants.
16. Any surgical or medical condition which might put the participant at risk in case of participation in the study. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following: At screening or baseline
- Lipase and/or amylase must not exceed the 1.5 x upper limit of normal (ULN)
- Liver disease or liver injury as indicated by abnormal liver function tests (LFT) (as defined below):
- Any of the following single parameters in serum of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), gamma-GT, alkaline phosphatase (ALP) or bilirubin must not exceed 1.5 x ULN.
- Any elevation above ULN of more than one parameter of ALT, AST, gamma-GT, ALP or serum bilirubin will exclude a participant from participation in the study.
- H
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All safety endpoints [i.e., vital signs, ECG parameters, clinical laboratories, and AEs, including SAEs] up to and including the End of Study (EOS) visit
- Secondary Outcome Measures
Name Time Method