A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-Severe Ulcerative Colitis

NCT07758101 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-7590-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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 ulcerative colitis.

Conditions

Moderate to Severe Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Adverse events

  From ICF signing date to Day 281

• Serious adverse events

  From ICF signing date to Day 281

Secondary Outcomes (8)

• Maximum observed concentration of SHR-7590 (Cmax)

  From 0 hour date to Day 281

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

  0 hour to Day 281

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

  0 hour to Day 281

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

  0 hour to Day 281

• Half-life (T1/2) of SHR-7590

  0 hour to Day 281

Study Arms (5)

Dose Level：A

EXPERIMENTAL

Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A.

Drug: SHR-7590; Drug: Placebo

Dose Level：B

EXPERIMENTAL

Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B.

Drug: SHR-7590; Drug: Placebo

Dose Level：C

EXPERIMENTAL

Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C.

Drug: SHR-7590; Drug: Placebo

Dose Level：D

EXPERIMENTAL

Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D.

Drug: SHR-7590; Drug: Placebo

Dose Level：E

EXPERIMENTAL

Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E.

Drug: SHR-7590; Drug: Placebo

Interventions

SHR-7590 DRUG

SHR-7590

Dose Level：A; Dose Level：B; Dose Level：C; Dose Level：D; Dose Level：E

Placebo DRUG

Placebo

Dose Level：A; Dose Level：B; Dose Level：C; Dose Level：D; Dose Level：E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Part 1
• 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
• Adopt efficient contraceptive measures

You may not qualify if:

• \- Part 1
• 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
• Acute infection with constitutional symptoms within 4 weeks before baseline
• Participants who participated in any drug or device clinical trial within 3 months before screening
• Use of any drug within 1 month before the use of the investigational drug
• Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening
• Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial
• History of blood donation within 1 month before screening, or severe blood loss

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Central Study Contacts

Si Chen

CONTACT

0518-82342973; si.chen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-07

Locations

CN (1)