A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

Study Purpose

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged 18
  • - 75 years, male or female; 2.
Subjects who have been diagnosed with ulcerative colitis; 3. Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose; 4. Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.

Exclusion Criteria:

1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis; 2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects; 3. Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period; 4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts; 5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening; 6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05770609
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Pharmaceuticals Holding Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Mild to Moderate Ulcerative Colitis
Arms & Interventions

Arms

Experimental: SPH3127 Tablets with Dose A

Oral daily dose of SPH3127 Tablets for up to 8 weeks

Experimental: SPH3127 Tablets with Dose B

Oral daily dose of SPH3127 Tablets for up to 8 weeks

Placebo Comparator: SPH3127 Tablets placebo

Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks

Interventions

Drug: - SPH3127 Tablets with Dose A

See Arm description

Drug: - SPH3127 Tablets with Dose B

See Arm description

Drug: - SPH3127 Tablets placebo

See Arm description

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080

Site Contact

Minhu Chen

chenminhu@vip.163.com

0086-020-87755766

Guangzhou, Guangdong, China

Status

Recruiting

Address

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655

Guangzhou, Guangdong, China

Status

Recruiting

Address

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong,

Site Contact

Mingsong Li

chenminhu@vip.163.com

0086-020-87755766

Huizhou First Hospital, Huizhou, Guangdong, China

Status

Recruiting

Address

Huizhou First Hospital

Huizhou, Guangdong,

Site Contact

Xuanfang Zhong

chenminhu@vip.163.com

0086-020-87755766

Shijiazhuang, Hebei, China

Status

Recruiting

Address

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei,

Site Contact

Xiaolan Zhang

chenminhu@vip.163.com

0086-020-87755766

Zhengzhou, Henan, China

Status

Recruiting

Address

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan,

Site Contact

Bingrong Liu

chenminhu@vip.163.com

0086-020-87755766

Wuhan, Hubei, China

Status

Recruiting

Address

Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology

Wuhan, Hubei, 430000

Site Contact

Xiaohua Hou

whunionlunli@126.com

0086-027-85726375

Wuhan, Hubei, China

Status

Recruiting

Address

Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030

Site Contact

Mei Liu

tongjilunli@163.com

0086-027-83691785

Renmin Hospital of Wuhan University, Wuhan, Hubei, China

Status

Recruiting

Address

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060

Hengyang, Hunan, China

Status

Recruiting

Address

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 675299

Site Contact

Aijun Liao

nhfyllwyh@163.com

0086-13789353900

Xuzhou, Jiangsu, China

Status

Recruiting

Address

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000

Site Contact

Sujuan Fei

xck2330@163.com

0086-0516-85802291

Shenyang, Liaoning, China

Status

Recruiting

Address

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110136

Site Contact

Changqing Zheng

sunw1@sj-hospital.org

0086-02496615-10027

Yinchuan, Ningxia, China

Status

Recruiting

Address

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004

Site Contact

Shaoqi Yang

nyfygk@126.com

0086-0951-6743648

Beijing, China

Status

Recruiting

Address

Beijing Chao-Yang Hospital,Capital Medical University

Beijing, , 100020

Site Contact

Jianyu Hao

chaoyangyuanban@126.com

0086-010-85231484

Peking University Third Hospital, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, ,

Site Contact

Shigang Ding

chenminhu@vip.163.com

0086-020-87755766

Chifeng Municipal Hospital, Chifeng, China

Status

Recruiting

Address

Chifeng Municipal Hospital

Chifeng, ,

Hangzhou, China

Status

Recruiting

Address

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, , 310003

Site Contact

Chunxiao Chen

chenminhu@vip.163.com

0086-020-87755766

Shanghai, China

Status

Recruiting

Address

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, , 200001

Site Contact

Jingyuan Fang

chobits86422@aliyun.com

0086-021-58752345

Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital;

Tianjin, , 300052

Site Contact

Bangmao Wang

master@tjmugh.com.cn

0086-022-60361044