Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects
- Conditions
- Pharmacokinetics
- Registration Number
- NCT06277284
- Lead Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria:<br><br> 1. Participants signed the informed consent form before the study, and fully understood<br> the content, process and possible adverse reactions of the study; Volunteer to<br> participate and be able to complete the study in accordance with the protocol<br> requirements.<br><br> 2. Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive)<br> at the time of signing the informed consent form;<br><br> 3. During the screening period, the body weight of male volunteers was =50 kg; Body<br> weight of women =45 kg, and body weight of men and women must not exceed 80 kg<br> (including 80 kg); Body mass index (BMI) in the range of 19.0-26.0kg/m2 (including<br> the boundary value;<br><br> 4. From the date of signing the informed consent to 6 months after the end of the<br> trial, the volunteers (including male volunteers) had no plans to have children and<br> voluntarily took effective non-drug contraceptive measures, and had no plans to<br> donate sperm or eggs.<br><br>Exclusion Criteria:<br><br> 1. Have any clinically serious disease history or are currently suffering from related<br> diseases, including but not limited to diseases of the digestive system,<br> cardiovascular system, respiratory system (such as asthma, etc.), urinary system,<br> musculoskeletal system, endocrine system, neuropsychiatric system, blood system,<br> immune system and other systems; Have any disorders such as coagulopathy (e.g.<br> hemophilia) or a history of haemorrhagic diseases such as hemorrhoids, acute<br> gastritis or gastric and duodenal ulcers; Patients with severe ocular diseases or<br> acute ocular inflammation (conjunctivitis, blepharitis, keratitis, etc.), dry eye or<br> pruritus; Have herpes virus infection;<br><br> 2. Those who have participated in and used the trial drug;<br><br> 3. Lactating and pregnant women, or women of childbearing age volunteers with positive<br> blood pregnancy test;<br><br> 4. Had a history of dizzy with needles and blood; Or patients with orthostatic<br> hypotension;<br><br> 5. Patients who had used immunosuppressant or immunopotentiator within 3 months before<br> drug administration;<br><br> 6. There are birthmarks, scars, tattoos, open wounds at the administration site (around<br> the umbilical cord);
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic: the maximum concentration (Cmax);Pharmacokinetic: area under the curve of o~t;Pharmacokinetic: area under the curve of o~8
- Secondary Outcome Measures
Name Time Method Safety evaluation index