Evaluation of 626 in Healthy Adult Subjects (NCT06674525) | Clinical Trial Compass
RecruitingPhase 1
Evaluation of 626 in Healthy Adult Subjects
China50 participantsStarted 2024-12-02
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* 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.
* Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.
Exclusion Criteria:
* 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.
* History of significant drug abuse.
* Subjects who have positive result for urine nicotine test at screening.
* Pregnant, or nursing females.