A Phase I Study of SHEN26 Capsule in Healthy Participants

NCT05504746 | Completed Phase 1

• 1 other identifier: KXZY-SHEN26-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, and placebo-controlled phase I clinical trial. It is designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules after single and multiple ascending dosing in healthy Chinese adult participants, and the food effect on the PK profile of SHEN26 capsules.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (7)

• AEs and SAEs

  The incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal Vital Signs

  Vital Signs: blood pressure (systolic and diastolic), pulse, body temperature (ear temperature), and respiratory rate. The number and percentage of participants with clinically significant abnormal vital signs will be noted.

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal Physical Examination Results

  Physical Examination: skin, lymph nodes, head and neck, chest, abdomen, spine/extremities/joints, and nervous system. The number and percentage of participants with clinically significant abnormal physical examination results will be noted.

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal Laboratory Values

  Laboratory Tests: CBC test, CMP test, urinalysis, urine microalbumin test, urinary NAG test, coagulation test, etc. The number and percentage of participants with clinically significant abnormal laboratory values will be noted.

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal Abdominal Ultrasound Results

  The number and percentage of participants with clinically significant abnormal abdominal ultrasound imaging test results, including liver, gallbladder, pancreas, spleen, and kidney, will be noted.

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal Ophthalmology Examination Results

  Ophthalmology Examination: slit lamp examination. The number and percentage of participants with clinically significant abnormal ophthalmological test results will be noted.

  From Screening period up to Day 12

• The Number and Percentage of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) Values

  12-lead Electrocardiogram (ECG): heart rate, PR, QRS, QT, and QTcF intervals. The number and percentage of participants with clinically significant abnormal 12-lead Electrocardiogram (ECG) values will be noted.

  From Screening period up to Day 12

Secondary Outcomes (19)

• Cmax After a Single Dose of SHEN26 capsule

  From predose to 72 hours postdose

• Tmax After a Single Dose of SHEN26 capsule

  From predose to 72 hours postdose

• AUC0-t and AUC0-inf After a Single Dose of SHEN26 capsule

  From predose to 72 hours postdose

• t1/2 After a Single Dose of SHEN26 capsule

  From predose to 72 hours postdose

• CL/F After a Single Dose of SHEN26 capsule

  From predose to 72 hours postdose

Study Arms (4)

SHEN26 capsule (SAD and FE part)

EXPERIMENTAL

SHEN26 capsule 50mg, 200mg, 400mg, 800mg, and 1200mg dose groups

Drug: SHEN26 capsule

SHEN26 capsule (MAD part)

EXPERIMENTAL

SHEN26 capsule 200mg, 400mg, and 600mg dose groups

Drug: SHEN26 capsule

SHEN26 placebo (SAD and FE part)

PLACEBO COMPARATOR

SHEN26 placebo 50mg, 200mg, 400mg, 800mg, and 1200mg dose groups

Drug: SHEN26 placebo

SHEN26 placebo (MAD part)

PLACEBO COMPARATOR

SHEN26 placebo 200mg, 400mg, and 600mg dose groups

Drug: SHEN26 placebo

Interventions

SHEN26 capsule DRUG

Specification: 50mg/capsule and 200mg/capsule. Participants will receive SHEN26 capsule(s) orally for a single dose. The specification of 50mg/capsule will only be used for the 50mg dose group in the SAD part. For the other dose groups and other parts of the study, 200mg/capsule will be used.

SHEN26 capsule (SAD and FE part)

SHEN26 placebo DRUG

Placebo matching the SHEN26 capsule. Specification: 50mg/capsule and 200mg/capsule. Participants will receive SHEN26 placebo orally for a single dose.

SHEN26 placebo (SAD and FE part)

Eligibility Criteria

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

You may qualify if:

• Healthy participants aged 18-45 years (including boundary values, based on the time of signing the informed consent);
• Body mass index (BMI) within the range of 19.0-26.0 kg/m\^2 (including boundary values), with body weight of not less than 50.0 kg for males and 45.0 kg for females;
• Participants were evaluated by the investigator on the basis of their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (CBC, CMP, urinalysis, urine microalbumin test, urinary NAG test, coagulation test, serum virology, blood alcohol content, drug abuse screening test, and blood pregnancy test, etc.), abdominal ultrasound, ophthalmologic examination, and chest CT for overall good health status (normal or abnormal test results without clinical significance);
• Fully understand the purpose, nature, methods, and possible adverse events of the trial, volunteer as a participant, and sign an informed consent form;
• The participant and their female partner have no birth plan and voluntarily use effective contraception methods and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and to ensure the use of one or more non-pharmacological contraceptive methods during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug.

You may not qualify if:

• Persons with pre-screening or ongoing disease with abnormal clinical manifestations to be excluded, including but not limited to diseases of the nervous/psychiatric system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal disorders affecting drug absorption), hematologic and lymphatic system, urinary system, endocrine system, and immune system；
• Persons with a history of febrile illness within 14 days prior to screening；
• Persons with dysphagia, history of gastrointestinal surgery or other related medical conditions that may interfere with the absorption and/or elimination of oral medications；
• Persons who have undergone major surgical procedures (excluding diagnostic surgery) within 3 months prior to screening that, in the judgment of the investigator, may interfere with this trial, or who are expected to require major surgery during the trial;
• Persons who have used or anticipate using any drug that induces or inhibits hepatic metabolic enzymes from 28 days prior to screening through the end of the trial;
• Persons who have used or expect to use inhibitors of BCRP prior to screening up to 72 h after the last dose;
• Persons who have used or expect to use inhibitors or inducers of P-gp prior to screening up to 72 h after the last dose;
• Persons who have used any prescription, over-the-counter, herbal or nutraceutical drug within 14 days prior to screening;
• Persons who have a history of substance abuse within 5 years prior to screening or who have used drugs in the 3 months prior to screening;
• Persons with a history of drug or other allergies, particularly to the test drug or any component of the test drug;
• Persons who have received any vaccine within 1 month prior to screening or who are scheduled to receive a vaccine during the trial;
• Persons who have a history of blood donation or blood loss of more than 400 mL within 3 months prior to screening, or plan to donate blood during the trial;
• Persons who have participated in other drug clinical trials and used other clinical trial drugs within 3 months prior to screening;
• Persons who have difficulties with venous blood collection or have a history of dizziness from needles and blood;
• Persons who smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months prior to screening, or cannot discontinue use of any tobacco product during the trial;

Sponsors & Collaborators

• Shenzhen Kexing Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Related Publications (2)

• Sun C, Liu H, Ouyang Z, Ding J, Zhang Q, Ma H, Xu D, Zhang Q, Zhou R, Yang M, Hu W. Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind Phase I study in healthy subjects. Expert Opin Investig Drugs. 2024 May;33(5):533-542. doi: 10.1080/13543784.2024.2347302. Epub 2024 Apr 30.

  PMID: 38662639 DERIVED

• Zhou Q, Yang S, Cao L, Yang Y, Xu T, Chen Q, Lu H, Li Y, Guo D, Zhang X. Preclinical characterization and anti-SARS-CoV-2 efficacy of ATV014: an oral cyclohexanecarboxylate prodrug of 1'-CN-4-aza-7,9-dideazaadenosine C-nucleoside. Signal Transduct Target Ther. 2023 Jan 12;8(1):27. doi: 10.1038/s41392-023-01310-0. No abstract available.

  PMID: 36635259 DERIVED

Study Officials

• Hui Zhao, MMed

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Wei Hu, MD

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 17, 2022
• Study Start: August 8, 2022
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)