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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Diabetic Neuropathy Peripheral

Treatments: Drug: 200mg; Drug: 100mg; Drug: 400mg; Drug: 50mg; Drug: 25mg; Drug: 800mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988413

SYHA1402201801/PRO-1

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 6 patient groups

25mg

Experimental group

Description:

Tablets, Oral, 25mg, single dose

Treatment:

Drug: 25mg

50mg

Experimental group

Description:

Tablets, Oral, 50mg, single dose

Treatment:

Drug: 50mg

100mg

Experimental group

Description:

Tablets, Oral, 100mg, single dose

Treatment:

Drug: 100mg

200mg

Experimental group

Description:

Tablets, Oral, 200mg, single dose

Treatment:

Drug: 200mg

400mg

Experimental group

Description:

Tablets, Oral, 400mg, single dose

Treatment:

Drug: 400mg

800mg

Experimental group

Description:

Tablets, Oral, 800mg, single dose

Treatment:

Drug: 800mg