A Clinical Trial of CS12192 in Healthy Subjects

NCT05922709 | Completed Phase 1

• 1 other identifier: CS12192-101
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.

Conditions

Healthy

Keywords

healthy

Outcome Measures

Primary Outcomes (5)

• the Number of Adverse Events (AEs)

  To investigate the safety and tolerability by assesment of AEs following administration.

  up to 14 days

• Pharmacokinetic parameters - Area Under the Curve(AUC)

  Area Under the Plasma Concentration-time Curve of CS12192.

  From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after the last dose for food effect study.

• Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)

  Maximum Observed Plasma Concentration of CS12192.

  From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after the last dose for food effect study.

• Pharmacokinetic parameters - Time of peak concentration(Tmax)

  Time to reach maximum observed plasma concentration of CS12192.

  From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses.From time 0 to 48 hours after the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.

• Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)

  Plasma Elimination Half-Life of CS12192.

  From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses.From time 0 to 48 hours after the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.

Study Arms (10)

CS12192 Cohort 1

EXPERIMENTAL

Subjects receive a single dose of 50 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 2

EXPERIMENTAL

Subjects receive a single dose of 150 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 3

EXPERIMENTAL

Subjects receive a single dose of 200 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 4

EXPERIMENTAL

Subjects receive a single dose of 300 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 5

EXPERIMENTAL

Subjects receive a single dose of 400 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 6

EXPERIMENTAL

Subjects receive 200 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 7

EXPERIMENTAL

Subjects receive 300 mg CS12192 or matching placebo, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 8

EXPERIMENTAL

Subjects receive 400 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7.

Drug: CS12192 capsule; Drug: Placebo capsule

CS12192 Cohort 9

EXPERIMENTAL

Subjects receive a single dose 400 mg CS12192 in either the fasted or fed state for two periods.

Drug: CS12192 capsule

CS12192 Cohort 10

EXPERIMENTAL

Subjects receive a single dose of 600 mg CS12192 or matching placebo.

Drug: CS12192 capsule; Drug: Placebo capsule

Interventions

CS12192 capsule DRUG

Participants receive CS12192 orally single or multiple doses

CS12192 Cohort 1; CS12192 Cohort 10; CS12192 Cohort 2; CS12192 Cohort 3; CS12192 Cohort 4; CS12192 Cohort 5; CS12192 Cohort 6; CS12192 Cohort 7; CS12192 Cohort 8; CS12192 Cohort 9

Placebo capsule DRUG

Participants receive placebo matching CS12192 orally single or multiple doses

CS12192 Cohort 1; CS12192 Cohort 10; CS12192 Cohort 2; CS12192 Cohort 3; CS12192 Cohort 4; CS12192 Cohort 5; CS12192 Cohort 6; CS12192 Cohort 7; CS12192 Cohort 8

Eligibility Criteria

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

You may qualify if:

• Healthy subjects, both male and female.
• Between18 and 45 years of age (inclusive) at screening visit.
• BMI between 19.0-26.0 kg/m2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
• All subjects and female partners of male agree to use medically recognized effective contraceptive measures (including physical contraception, surgical contraception, abstinence, etc.) from the start of signing informed consent form to 3 months after the last dose.
• Subjects voluntarily participate in the study and sign informed consent form.

You may not qualify if:

• History of clinically significant drug allergy or atopic allergic diseases (asthma, urticaria, eczematous dermatitis) or drug allergy to investigational products or similar investigational products.
• History of cardiovascular system, endocrine system, nervous system disease or lung, hematological, immunological, psychiatric diseases and metabolic abnormalities.
• History or surgical history of gastrointestinal, hepatic, or renal disease that can affect drug absorption or metabolism within 6 months prior to the screening visit (except uncomplicated appendectomy and hernia repair).
• History of active tuberculosis, or positive tuberculosis screening at screening visit.
• History of any recurrent bacterial, fungal or viral infections (≥3 attacks in the past year, except the common cold), or active infections requiring treatment at screening visit, or history of infection requiring intravenous anti-infective drugs or hospitalization ≤8 weeks before randomization, or history of infection requiring oral anti-infective drugs ≤2 weeks before randomization.
• Uncured diarrhea before randomization, or history of diarrhea within 7 days before planning dosing.
• Use of any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 1 month before randomization.
• History of drug abuse.
• Inability to tolerate venipuncture, or history of fainting or halo.
• Participation in interventional clinical study (device or drug) within 3 months prior to randomization, or taking investigational product within 3 months prior to randomization , or remaining within 5 half-lives of drug, whichever is longer.
• Blood donation or significant blood loss (\>300 mL) within 3 months prior to randomization.
• Pregnant or lactating females, or female subjects with serum pregnancy test human chorionic gonadotropin (HCG) ≥5 mIU/mL.
• History of regular alcohol consumption, drinking more than 7 cups per week for females or 14 cups per week for males (1 cup= 100 mL wine = 285 mL beer = 25 mL spirits) within 3 months before randomization; or taking any products containing alcohol within 48 hours before the first dose; or having a positive alcohol breath test before randomization.
• Smoking more than 5 cigarettes or equivalent per day within 3 months prior to randomization or inability to refrain from smoking during the trail.
• Excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups) per day within 14 days before randomization, or tea, coffee, caffeinated beverages or foods within 48 hours before randomization.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

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: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study use a randomized, double-blind, placebo-controlled dose-escalation design. The FE study use a randomized, open-label, two-period, two-crossover design.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 28, 2023
• Study Start: July 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)