Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

• Status: Completed
• Trial end date: 2020-01-14
• Target enrollment: 0
• Participant gender: All

Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

Inclusion Criteria:

1. 18≤Age≤45, male or female;

2. Body weight (> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (< BMI) = 26.0 kg/m2);

3. Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;

4. All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;

5. Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

Exclusion Criteria:

1. Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;

2. Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;

3. Surgery history within six months before signing the informed consent;

4. Allergic history to more than one drug or other serious allergic rhistory.

5. Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;

6. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;

7. History of drugs or drug abuse or alcoholics;

8. History of blood donation more than 200 mL within 8 weeks before signing informed consent;

9. Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;

10. Not suitable for this trial according to the investigator.