A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles and Food Effect of CS32582 Capsules

NCT06224595 | Completed Phase 1

• 1 other identifier: CS32582-101
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Incidence and Severity of Adverse Events (AEs)

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

  From the time of signing the informed consent form to 7 days after the last administration of the drug

• Pharmacokinetic parameters - Area Under the Curve(AUC)

  Area Under the Plasma Concentration-time Curve of CS32582.

  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 each period's dosing for food effect study.

• Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)

  Maximum Observed Plasma Concentration of CS32582.

  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 each period's dosing for food effect study.

• Pharmacokinetic parameters - Time of Peak Concentration(Tmax)

  Time to reach maximum observed plasma concentration of CS32582.

  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 each period's dosing for food effect study.

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

  Plasma Elimination Half-Life of CS32582.

  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 each period's dosing for food effect study.

Study Arms (11)

CS32582 Cohort 1

EXPERIMENTAL

Subjects receive a single dose of 3 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 2

EXPERIMENTAL

Subjects receive a single dose of 6 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 3

EXPERIMENTAL

Subjects receive a single dose of 12 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 4

EXPERIMENTAL

Subjects receive a single dose of 24 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 5

EXPERIMENTAL

Subjects receive a single dose of 36 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 6

EXPERIMENTAL

Subjects receive a single dose of 54 mg CS32582 or matching placebo

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 7

EXPERIMENTAL

Subjects receive a single dose 12 mg CS32582 in either the fasted or fed state for two periods

Drug: CS32582 capsule

CS32582 Cohort 8

EXPERIMENTAL

Subjects receive 3 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10.

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 9

EXPERIMENTAL

Subjects receive 6 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10.

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 10

EXPERIMENTAL

Subjects receive 12 mg CS32582 or matching placebo for 10 days, once daily from Day 1 to Day 10.

Drug: CS32582 capsule; Drug: Placebo capsule

CS32582 Cohort 11

EXPERIMENTAL

Subjects receive 12 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10.

Drug: CS32582 capsule; Drug: Placebo capsule

Interventions

CS32582 capsule DRUG

Participants receive CS32582 orally single or multiple doses

CS32582 Cohort 1; CS32582 Cohort 10; CS32582 Cohort 11; CS32582 Cohort 2; CS32582 Cohort 3; CS32582 Cohort 4; CS32582 Cohort 5; CS32582 Cohort 6; CS32582 Cohort 7; CS32582 Cohort 8; CS32582 Cohort 9

Placebo capsule DRUG

Participants receive placebo matching CS32582 orally single or multiple doses

CS32582 Cohort 1; CS32582 Cohort 10; CS32582 Cohort 11; CS32582 Cohort 2; CS32582 Cohort 3; CS32582 Cohort 4; CS32582 Cohort 5; CS32582 Cohort 6; CS32582 Cohort 8; CS32582 Cohort 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects, both male and female.
• Between18 and 55 years of age (inclusive) at screening visit.
• BMI between 19.0-26.0 kg/m\^2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
• Subject is medically healthy or judged by the investigator to be abnormal but clinically insignificant based on the results of history inquiry, physical examination, vital signs, standard 12-lead electrocardiogram, X-ray, abdominal ultrasound examination, and clinical laboratory tests at the time of screening visit.
• All subjects and female partners of male agree to use medically recognized effective methods of contraception (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, respiratory system, digestive system, liver, kidney, blood and lymphatic system, immune system, psychiatric diseases and metabolic abnormalities.
• Conditions that may affect the determination of skin adverse events related to the investigational drug, including but not limited to sunburn, excessive tattooing (covering more than 25% of body surface area), or existing acne extending beyond sebum-prone areas (i.e., arms, torso, back, buttocks, and/or genital area).
• History of myalgia or rhabdomyolysis.
• History of hereditary hyperbilirubinemia.
• History of gastrointestinal, hepatic, or renal diseases or surgeries within the past 6 months that could affect drug absorption or metabolism, excluding uncomplicated appendectomy and hernia repair.
• History of active tuberculosis or positive tuberculosis at the screening visit.
• History of recurrent bacterial, fungal, or viral infections (≥3 occurrences in the past year, excluding common cold), or active infection requiring treatment at the screening visit, or history of infection within ≤8 weeks before baseline visit requiring intravenous anti-infective drugs and/or hospitalization, or history of infection requiring oral anti-infective drugs ≤2 weeks before baseline visit.
• Untreated diarrhea at baseline visit or diarrhea symptoms within 7 days before the planned first dose.
• History of drug abuse.
• Vaccination within the past 3 months at the screening visit or plans for any vaccination during the study.
• Participation in an interventional clinical trial (device or drug) within the past 3 months or use of investigational drugs within the past 3 months or still within 5 half-life of that drug (whichever is longer) at the screening visit.
• Blood donation or significant blood loss (\>300 mL) within the past 3 months at the screening visit.
• Use of any prescription drugs, non-prescription drugs, any vitamin products, or herbal products within the past month before baseline visit.
• Inability to tolerate venepuncture or history of needle or blood-related fainting.

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), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are a randomized, double-blind, placebo-controlled dose-escalation design. The FE study is a randomized, open-label, two-period, two-crossover design.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: March 28, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)