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A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults

ConditionCutaneous Lupus Erythematosus(CLE)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.

Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)

Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods

Female participants: not pregnant or lactatin

Disqualifiers

Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment

Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection

Patients with chronic or recurrent infection requiring treatment within 12 months before screening

A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-7012 injection ; placebo

    Drug

    A single subcutaneous injection of Dose1 SHR-7012 injection or placebo was administered

  • SHR-7012 injection ; placebo

    Drug

    A single subcutaneous injection of Dose2 SHR-7012 injection or placebo was administered

  • SHR-7012 injection ; placebo

    Drug

    A single subcutaneous injection of Dose3 SHR-7012 injection or placebo was administered

  • SHR-7012 injection ; placebo

    Drug

    A single subcutaneous injection of Dose4 SHR-7012 injection or placebo was administered

  • SHR-7012 injection ; placebo ;

    Drug

    A single subcutaneous injection of Dose5 SHR-7012 injection or placebo was administered

Treatment groups

50 Participants
are divided into 5 treatment groups
Group A: Treatment group 1: Dose1 Injection of SHR-7012 or placeboExperimental treatment 1 intervention
Group B: Treatment group 2: Dose2 Injection of SHR-7012 or placeboExperimental treatment 1 intervention
Group C: Treatment group 3: Dose3 Injection of SHR-7012 or placeboExperimental treatment 1 intervention
Group D: Treatment group 4: Dose4 Injection of SHR-7012 or placeboExperimental treatment 1 intervention
Group E: Treatment group 5: Dose5 Injection of SHR-7012 or placeboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability : Incidence and severity of any adverse events

Time frame
Evaluation was performed up to Day141

Secondary outcomes

1

AUC0-t

Time frame
Evaluation was performed up to Day113 or Day141
2

AUC0 ∞

Time frame
Evaluation was performed up to Day113 or Day141
3

Tmax

Time frame
Evaluation was performed up to Day113 or Day141
4

Cmax

Time frame
Evaluation was performed up to Day113 or Day141

Other outcomes

Sponsors and contacts

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

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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