A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willingness to provide written informed consent for the study.

Male or female subjects, age 18-45 years older.

Within body mass index (BMI) range 19.0 to 26.0 kilograms per square meter (kg/m²).

The results of vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray and other examinations during the screening period are normal or judged to be abnormal by the investigator and have no clinical significance.

Disqualifiers

History of severe allergies or allergies to 611 and any of its components;

Previous or current disease that may affect the safety of the subject's participation in the trial or the in vivo process of the trial drug;

Any history of VKC and AKC;

History of drug abuse within 2 years prior to screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • new formulations of 611

    Drug

    Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1

  • existing formulations of 611

    Drug

    Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Tested preparation groupExperimental treatment 1 intervention
Group B: Reference preparation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Time frame
57 days
2

AUC

Time frame
57 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: