A First-in-human Phase 1 Study of CP1050

Curadim Pharma

Status and phase: Unknown; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: CP1050 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03468413

CP1050-E101

Details and patient eligibility

About

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).

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Single ascending dose, CP1050 or Placebo

Experimental group

Treatment:

Drug: CP1050 or Placebo

Multiple ascending dose, CP1050 or Placebo

Experimental group

Treatment:

Drug: CP1050 or Placebo