A First-in-human Phase 1 Study of CP1050

NCT03468413 | Unknown Phase 1

• 1 other identifier: CP1050-E101
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).

Conditions

Healthy Subjects

Keywords

CP1050; Phase 1; Healthy subjects

Outcome Measures

Primary Outcomes (8)

• Incidence and severity of any drug-related adverse events

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events

  Up to 21 days

• Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature)

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs

  Up to 21 days

• Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis)

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests

  Up to 21 days

• Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF])

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG

  Up to 21 days

• Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria)

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG

  Up to 21 days

• Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only])

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests

  Up to 21 days

• Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments

  Up to 21 days

• Number of subjects with abnormal physical examinations

  To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations

  Up to 21 days

Secondary Outcomes (8)

• Maximum observed plasma concentration (Cmax)

  Up to 21 days

• Area under the plasma concentration-time curve (AUC)

  Up to 21 days

• Time of maximum observed plasma concentration (Tmax)

  Up to 21 days

• Apparent plasma terminal elimination half-life (T1/2)

  Up to 21 days

• The lowest absolute value of lymphocytes at postdose (nadir)

  Up to 21 days

Study Arms (2)

Single ascending dose, CP1050 or Placebo

EXPERIMENTAL

Drug: CP1050 or Placebo

Multiple ascending dose, CP1050 or Placebo

EXPERIMENTAL

Drug: CP1050 or Placebo

Interventions

CP1050 or Placebo DRUG

Randomised, double-blinded, placebo-controlled

Multiple ascending dose, CP1050 or Placebo; Single ascending dose, CP1050 or Placebo

Eligibility Criteria

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

You may qualify if:

• Caucasian males or females between 18 and 55 years of age (inclusive).
• A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
• Healthy and free from clinically significant illness or disease.

You may not qualify if:

• Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
• Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
• Clinically significant abnormalities in ECG or laboratory tests.

Sponsors & Collaborators

• Curadim Pharma Co., Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 16, 2018
• Study Start: February 5, 2018
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)