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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 626

    Drug

    Single subcutaneous injection

  • Placebo

    Drug

    Single subcutaneous injection

Treatment groups

50 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 626 Group S1 for subcutaneous injectionExperimental treatment 2 interventions
Group B: 626 Group S2 for subcutaneous injectionExperimental treatment 2 interventions
Group C: 626 Group S3 for subcutaneous injectionExperimental treatment 2 interventions
Group D: 626 Group S4 for subcutaneous injectionExperimental treatment 2 interventions
Group E: 626 Group S5 for subcutaneous injectionExperimental treatment 2 interventions
Group F: 626 Group S6 for subcutaneous injectionExperimental treatment 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
90 days

Secondary outcomes

1

Cmax

Peak concentration (Cmax) will be calculated.

Time frame
90 days
2

Tmax

Time to peak concentration (Tmax) will be calculated.

Time frame
90 days
3

AUC0-last

Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated.

Time frame
90 days
4

Incidence of Anti-Drug Antibody

Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive.

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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