A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects

NCT04453618 | Unknown Phase 1

• 1 other identifier: HA1403-CSP-002；V1.0
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (4)

• Effect of food on the pharmacokinetic(Cmax）

  Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).

  Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions

• Effect of food on the pharmacokinetic(AUC0-inf）

  Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).

  Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions

• Effect of food on the pharmacokinetic(AUC0-t）

  Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).

  Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions

• Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).

  incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams

  up to 5 days after the last dose

Secondary Outcomes (12)

• Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)

  up to 4 days after the last dose

• AUC0-t(Part2)

  Predose and multiple timepoints up to 24 hours after the last dose

• AUC0-inf(Part2)

  Predose and multiple timepoints up to 24 hours after the last dose

• Cmax(Part2)

  Predose and multiple timepoints up to 24 hours after the last dose

• Tmax(Part2)

  Predose and multiple timepoints up to 24 hours after the last dose

Study Arms (4)

Food effect

EXPERIMENTAL

Healthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal.

Drug: FE-SYHA1402 100mg

Multiple doses 25mg

EXPERIMENTAL

Healthy subjects receive multiple doses of SYHA1402 (25mg) or Placebo(25mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.

Drug: SYHA1402-25mg; Drug: Placebo-25mg

Multiple doses 50mg

EXPERIMENTAL

Healthy subjects receive multiple doses of SYHA1402 (50mg) or Placebo (50mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.

Drug: SYHA1402-50mg; Drug: Placebo-50mg

Multiple doses 150mg

EXPERIMENTAL

Healthy subjects receive multiple doses of SYHA1402 (150mg) or Placebo (150mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.

Drug: SYHA1402-150mg; Drug: Placebo-150mg

Interventions

FE-SYHA1402 100mg DRUG

in either a fasted state or with a meal

Food effect

SYHA1402-25mg DRUG

SYHA1402 25mg, oral tablets

Multiple doses 25mg

Placebo-25mg DRUG

Matching placebo tablets

Multiple doses 25mg

SYHA1402-50mg DRUG

SYHA1402 50mg, oral tablets

Multiple doses 50mg

Placebo-50mg DRUG

Matching placebo tablets

Multiple doses 50mg

SYHA1402-150mg DRUG

SYHA1402 150mg, oral tablets

Multiple doses 150mg

Placebo-150mg DRUG

Matching placebo tablets

Multiple doses 150mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged 18 to 45 years (inclusive).
• Have a body mass index (BMI) between 19.0 and 26.0 kg/m2 inclusive and weigh at least 45.0 kg (female) or 50.0 kg (male) inclusive at screening.
• With no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests.
• All subjects of reproductive potential must agree to use effective, non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs) from the signing of informed consent to 3 months after the study. A subject is eligible to participate if she/he is not a person of childbearing potential (had a bilateral oophorectomy, bilateral salpingo-oophorectomy, or vasectomy). A male subject refrains from donating sperm during the study period and for 3 months after the study.
• Signed informed consent form.

You may not qualify if:

• Female subjects who are pregnant or lactating.
• History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, renal, or other major disease, as determined by the investigator.
• Surgery history within six months before signing the informed consent;
• Allergic history to more than one drug or other serious allergic history.
• Any other abnormal findings on vital signs
• Any clinically significant abnormalities in ECG: a QTc interval greater than 450 ms (male) or 470 ms (female), or with a history of prolonged QTc interval;
• Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (anti-HCV), Human immunodeficiency virus antibody (anti-HIV) or Treponema Pallidum antibody (Anti-TP) at screening.
• Use of drugs within 2 weeks before signing the informed consent, including over-the-counter or prescription medication, including biological product, Chinese traditional medicine, herbal medicine, vitamin dietary supplements, health care products, oral or imbedded long-acting contraceptives.
• Alcohol abuse or positive test for alcohol screening.
• Smoker.
• History or clinical evidence of drug abuse within the one years before screening, or positive test for drug abuse at screening.
• Use of too much caffeine in beverages, foods or in any form, which may interfere the absorption, distribution, metabolism, or excretion of drugs, within 4 weeks before signing informed consent
• Loss of blood or blood donation more than 200 mL within 8 weeks before signing informed consent, or plan on blood donation during the study period and 1 months after the last dose of drug.
• Have a surgical schedule or a plan on excessive physical activity during the study period.
• Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Central Study Contacts

Yanping Liu

CONTACT

0311-67808817; liuyanping@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06