Health TrialsbyHealthPanel

A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease

ConditionModerate-to-severe Inflammatory Bowel Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe inflammatory bowel disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Voluntarily signed the informed consent form

Age from 18 to 55 years old

Body weight ≥45 kg, body mass index (BMI) 18-26 kg/m2

Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations

Disqualifiers

Suspected allergy to the study drug or any component of the study drug

Any clinical disease or any other disease that could interfere with the test results

Had a history of malignant tumor

Had an opportunistic infection within 6 months before screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-7590

    Drug

    SHR-7590

  • Placebo

    Drug

    Placebo

Treatment groups

88 Participants
are divided into 5 treatment groups
Group A: Dose Level：AExperimental treatment 2 interventions
Group B: Dose Level：BExperimental treatment 2 interventions
Group C: Dose Level：CExperimental treatment 2 interventions
Group D: Dose Level：DExperimental treatment 2 interventions
Group E: Dose Level：EExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse events

Time frame
From ICF signing date to Day 281
2

Serious adverse events

Time frame
From ICF signing date to Day 281

Secondary outcomes

1

Maximum observed concentration of SHR-7590 (Cmax)

Time frame
From 0 hour date to Day 281
2

Time to maximum observed concentration (Tmax) of SHR-7590

Time frame
0 hour to Day 281
3

Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590

Time frame
0 hour to Day 281
4

Area under the drug-time curve from time 0 to infinity of SHR-7590（AUC0-inf）

Time frame
0 hour to Day 281

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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