A Study Evaluating the Food Effect on the Pharmacokinetics of SSS17 Capsules in Chinese Healthy Subjects

NCT07024888 | Completed Phase 1

• 1 other identifier: SSS17-103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study mainly compared the blood drug concentration and main pharmacokinetic parameters of SSS17 capsules taken orally once by healthy Chinese subjects under fasting conditions, 2 hours after administration, and when consuming a high-fat meal or a low-fat meal simultaneously. The study evaluated the impact of food on SSS17 capsules.

Conditions

Healthy Subjects (HS)

Outcome Measures

Primary Outcomes (2)

• Cmax

  Day1 to Day73

• AUC

  Day 1 to Day 73

Secondary Outcomes (4)

• Tmax

  Day1 to Day73

• t1/2

  Day 1 to Day 73

• CL/F

  Day 1 to Day 73

• AEs

  up to Day 73

Study Arms (3)

Fasting Group

OTHER

Drug: SSS17

Low-fat Meal Concomitant Administration Group

OTHER

Drug: SSS17

High-fat Meal 2-Hour Post-dose Group

OTHER

Drug: SSS17

Interventions

SSS17 DRUG

Single oral administration of SSS17

Fasting Group; High-fat Meal 2-Hour Post-dose Group; Low-fat Meal Concomitant Administration Group

Eligibility Criteria

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

You may qualify if:

• Healthy adult subjects aged 18 to 45 years
• Good health status with no clinically significant medical history.
• Agreement to use effective contraception from signing ICF until 6 months after trial completion, with no reproductive plan.
• Voluntarily sign informed consent form (ICF), capable of protocol compliance and scheduled follow-up

You may not qualify if:

• Hypersensitivity to investigational drug/excipients.
• Dysphagia, GI disorders affecting absorption, or relevant surgery history .
• Intolerance to venipuncture or needle/blood phobia.
• Clinically significant disorders affecting drug ADME.
• Clinically significant abnormalities in vital signs/PE/labs/12-lead ECG/chest X-ray at screening.
• Family history of malignancy or major surgery within 3 months pre-screening.
• Participation in other drug/device trials with investigational product use within 3 months.
• Blood donation/loss within 3 months.
• Special diets (pitaya/grapefruit products) or strenuous exercise within 7 days pre-dosing affecting ADME.
• Any medication use within 14 days pre-dosing.
• Regular alcohol \>14 units/week within 3 months.
• Smoking \>5 cigarettes/day within 3 months or unwilling to abstain during trial.
• Caffeine products within 48h pre-dosing.
• Alcohol consumption within 48h or positive alcohol screen.
• Positive serology for HBsAg, HCV Ab, HIV Ab, or syphilis.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The Affilated Hospital Of QingDao University

Qingdao, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 17, 2025
• Study Start: March 16, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (1)