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A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of EVER206 Intravenous Infusion in Healthy Chinese Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of EVER206 Intravenous Infusion in Healthy Chinese Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056692
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-02-10
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Case group:None

Sponsors

Huashan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Healthy Chinese subjects aged from 18 to 45, male and female; 2. BMI range 19~26 kg/m2 (included), and body weight = 50 kg; 3. Good health; 4. Take effective contraceptive measures during the study period; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of allergy to polymyxin drugs; 2. Have a history of allergic disease, kidney disease, nervous system or heart disease/family history; 3. People with acute and chronic infection, or any infectious diseases within 4 weeks before administration; 4. Those who are smoking within 3 months before screening and cannot be banned from smoking in the test, or drink excessively or contain caffeine within 6 months; 5. Major surgery was performed within 3 months before the first dose, or blood donation or blood loss exceeded about 400ml; 6. Use the drug 2 weeks before the first dose or within the expected 5 half-life of the drug; 7. Any vaccine has been vaccinated within 1 month before screening, and there is a vaccination plan during the study; 8. Participated in any intervention clinical study within 3 months before screening; 9. Within 90 days after the last dose, the female subjects or male subjects' female partners have a pregnancy plan, and the male subjects have a sperm donation plan; 10. Female subjects are pregnant or nursing; 11. ECG, vital signs, transaminase and serum total IgE were abnormal during screening period, with eGFR<90 ml/min; 12. HIV-Ab, HBs-Ag, HCV-Ab, TPPA test; 13. Positive results of urine drug screening/alcohol screening/nicotine test; 14. There is no suitable vein for puncture or blood sample collection cannot be tolerated; 15. Do not abide by alcohol, smoking cessation and other dietary restrictions during hospitalization.

Contacts

Public ContactKevin Li

Everest Medicines (China) CO., LTD

Kevin.Li@everestmedicines.com+86 13911359526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026