A First-in-human Phase 1 Study of CP1050

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2019-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Single ascending dose, CP1050 or Placebo

Group Type EXPERIMENTAL

CP1050 or Placebo

Intervention Type DRUG

Randomised, double-blinded, placebo-controlled

Multiple ascending dose, CP1050 or Placebo

Group Type EXPERIMENTAL

CP1050 or Placebo

Intervention Type DRUG

Randomised, double-blinded, placebo-controlled

Interventions

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CP1050 or Placebo

Randomised, double-blinded, placebo-controlled

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes