A parallel, Phase 1, randomized, open label study to evaluate the pharmacokinetics, safety and tolerability of single subcutaneous dose amlitelimab in healthy Chinese and Japanese adult participants.
- Conditions
- Not Applicable
- Registration Number
- KCT0008635
- Lead Sponsor
- Sanofi-Aventis Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Participants are eligible to be included in the study only if all of the following criteria apply.
I 01. Chinese or Japanese male and female adult participants, between 20 and 45 years of age, inclusive, at the time of signing the informed consent. The origin classification as Chinese or Japanese is defined according to the following
- Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.
- Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.
Type of participant and disease characteristics
I 02. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests.
I 03. Vital signs in supine position after 10 minutes resting within the following ranges:
- 95 mmHg < systolic blood pressure (SBP) <140 mmHg.
- 45 mmHg < diastolic blood pressure (DBP) <90 mmHg.
- 45 bpm < heart rate (HR) <100 bpm.
I 04. Standard 12-lead ECG parameters after 10 minutes resting in supine position in the following ranges; 120 ms <220 ms, QRS <120 ms, QTc =450 ms (Fridericia algorithm recommended), 45 bpm < HR <100 bpm and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
I 05. Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant; however, serum creatinine, alkaline phosphatase, hepatic enzymes (aspartateaminotransferase [AST], alanine transaminase [ALT]), should not exceed the upper laboratory norm. Total bilirubin out of normal range can be acceptable if total bilirubin does not exceed 1.5 the upper limit with normal conjugated bilirubin values
(unless the participant has documented Gilbert syndrome, for which total bilirubin =3 the
upper limit is acceptable).
I 06. Body weight within the range from 50 to 100 kg and body mass index (BMI) within the
range from 18-30 kg/m2 (inclusive).
, contraceptive/barrier method and pregnancy testing requirements>
I 07. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a) Male participants
Male participants are eligible to participate if they agree to the following from signing of the informed consent until 6 months after the administration of study intervention:
• Refrain from donating or cryopreserving sperm PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception/barrier as detailed below
- A male condom and an additional highly effective contraceptive method as described in Appendix 4 Contraceptive and barrier guidance (Section 10.4) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
b) Female participants
• A
Participants are excluded from the study if any of the following criteria apply:
E 01. Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness,
unless the investigator considers an abnormality to be not clinically significant.
E 02. Serious infections requiring hospitalization within 30 days prior to screening or any active or chronic infection requiring systemic treatment within 2 weeks prior to baseline (1 week in the event of superficial skin infections).
E 03. Have basal or squamous cell skin cancer in the last 3 years prior to baseline. Any other malignancies not in remission within the past 5 years prior to baseline (excluding in situ cervical carcinoma that has been excised and cured).
E 04. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
E 05. Blood donation within 2 months before inclusion (Note: For the site in Japan, blood donation of 400 mL within 12 weeks [for male] or 16 weeks [for female], 200 mL within 4 weeks or apheresis donation within 2 weeks before the first IMP administration).
E 06. Symptomatic postural hypotension, irrespective of the decrease in blood pressure (BP), or asymptomatic postural hypotension defined as a decrease in SBP =30 mmHg within 3 minutes when changing from supine to standing position.
E 07. Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician. Participants with a history of mild seasonal allergies may be included at the Investigator's discretion.
E 08. History (within last 2 years prior to baseline) or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
E 09. Smoking regularly more than 10 cigarettes daily, unable to stop smoking during the institutionalization (occasional smoker can be enrolled).
E 10. Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
E 11. Elective surgery planned to be scheduled for any time in the period up to 3 months following the last dose of IMP.
/concomitant therapy>
E 12. Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
E 13. Treatment with a live (attenuated) immunization within 12 weeks prior to IMP administration; administrations of COVID-19 vaccine within 14 days prior to IMP administration.
/concurrent clinical study experience>
E 14. At the time of screening, any participant enrolled in or having participated, in this or any other clinical study, receiving an IMP within 6 months (Note: For the site in Japan, receiving an IMP within 4 months) before the first study drug administration.
E 15. Positive result on any of the following tests: hepatitis B su
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whenever measurements of vital signs, ECG, and blood samples for PK, or safety coincide, the following order will be respected: ECG, vital signs, PK, and then blood safety samples. In order to respect exact timing of PK samples (refer to flow chart for time window allowance for PK samples), the other measurements will be done ahead of the scheduled time.
- Secondary Outcome Measures
Name Time Method