A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults (NCT06494527) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults
China30 participantsStarted 2024-10-18
Plain-language summary
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects who are able to communicate well with the investigator, understand and follow trial requirements, voluntarily participate in the trial, understand and sign Informed Consent Form (ICF);
✓. Healthy adult subjects aged 18 to 60 years (inclusive), male or female;
✓. BMI18-32 kg/m2 ;
✓. Subjects who have no current or past medical history of clinically significant diseases of the circulatory system, digestive system, nervous system, respiratory system, and urinary system, mental disorders, or metabolic disorders or history of such disease; and whose physical examination, vital signs, electrocardiogram, chest X-ray or blood test and laboratory tests show normal results or abnormal but not clinically significant results (subject to clinical judgment) at the time of screening.
✓. WOCBP must have a negative serum pregnancy test and must not be breastfeeding, lactating or planning pregnancy during the study period.
✓. A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period.
✓. Evidence of vaccination (medical record and/or positive antibody test) against Neisseria meningitidis infection (types A, C, W and Y and Group B), Streptococcus pneumoniae, and Haemophilus influenzae type b infection is required before initiation of the investigational drug or placebo.
Exclusion criteria
✕. Known or persistent mental disorders that require medication intervention and may interfere with the subject's participation in the study.
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
. Presence or suspicion of active viral, bacterial, fungal or parasitic infections;
✕. History of recurrent or chronic infections;
✕. History of epidemic meningococcal infection;
✕. History of splenectomy or asplenia;
✕. History of complement abnormalities or hereditary complement deficiencies;
✕. Any skin conditions and/or tattoos that may interfere with the safety assessment of the injection site, or any relevant history of abdominal scar (surgery, burns, etc.);
✕. Subjects who have tested positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and treponema pallidum antibody (optional );