Evaluation of 627 in Healthy Adult Subjects
ConditionHealthy Subjects (HS)
Trial statusNot yet recruiting
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 and multiple ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-627 in healthy adult subjects after single subcutaneous injection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
History of of significant alcohol abuse.
History of significant drug abuse.
Subjects who have positive result for urine nicotine test at screening.
Trial design
Design model
Parallel
Treatments tested in this trial
627
Biological/Vaccinesubcutaneous injection
Placebo
Other interventionSingle subcutaneous injection
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: 627Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with Adverse Events
Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
Time frame
D99Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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