PCO-02 - Safety and Pharmacokinetics Trial

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaCotherapia d.o.o.
• Collaborator: Hospital Ángeles Tijuana
• Treatments: BPC 157

Criteria

Inclusion Criteria:

• Both genders, between the ages of 18 and 35 years old.

• Willing and able to provide informed consent.

• Body Mass Index between 18.5 and 24.9 (normal)

• Normal blood work, according to following criteria: Leucocytes >3,000; Platelets >100,000; Hemoglobin >10.0 g/dL; AST, ALT and bilirubin < 2 times UNL; Creatinine < 2 times UNL.

• Normal ECG and chest x-rays, at the discretion of the cardiologist and radiologist, respectively.

• Negative urine pregnancy test (Women in childbearing age, sexually active).

• Willing to return for follow-up as required by the study.

Exclusion Criteria:

• History of psychiatric condition.

• Pregnant or lactating women.

• Clinically significant abnormalities on the ECG.

• Presence of medical or social conditions that, in opinion of the investigator, may prevent the proper participation of the volunteer subject in the study or in the assessment of its outcomes.

• Presence of an active systemic infection.

• Subjects receiving medical treatment for any medical condition, either acute or chronic.

• Recent (< 6 months) major surgery.

• Recent (< 1 year) alcohol abuse or illegal drug use.