Evaluation of 626 in Healthy Adult Subjects
ConditionHealthy Subjects (HS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About this trial
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Eligibility criteria
Qualifiers
Able to understand protocol requirements and sign a written ICF.
Male or female subjects aged 18-45 years when signing the ICF.
Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m2.
Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
Disqualifiers
History of severe allergy, or with a history of allergy to the study treatment or related excipients.
With any clinically significant diseases prior to the screening visit.
Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
History of of significant alcohol abuse.
Trial design
Treatments tested in this trial
- 626
- Placebo
Treatment groups
50 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov