A Randomized, Double-blind, Placebo-controlled, Single/Multiple Ascending Dose, Phase 1 International Multi-center Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of RG002C0106 Injection in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- RG002C0106
- Conditions
- Safety Issues
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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
Detailed Description
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 There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg，and the highest dose will be mainly determined based on the data obtained during the study process. There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.
Investigators
Eligibility Criteria
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.
- •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 );
- •Hepatic function abnormal.
- •Renal function abnormal.
Arms & Interventions
RG002C0106
Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration
Intervention: RG002C0106
placebo
Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration
Intervention: RG002C0106
Outcomes
Primary Outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug
Time Frame: up to 169 days
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug