A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

REPEC

Registry ID

PER-021-17

Enrollment

Registered

2017-11-27

Start date

2017-07-17

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K73 NULL NULL

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start. • Volunteers signing the informed consent form to take part in the clinical trial. • Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months. • Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator.

Exclusion criteria

Exclusion criteria: • Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start. • Volunteers signing the informed consent form to take part in the clinical trial. • Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months. • Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator. • Volunteers with any known chronic disease or diagnosed during the evaluation process or who have symptoms of an acute disease. • Pregnant, postpartum or breastfeeding women. • Childbearing women who wish to become pregnant within 3 months after the clinical trial start. • Volunteers taking any type of drug or vitamin supplement. • Subjects who have participated in other study within the last 30 days prior this clinical trial. • Subjects with legal or pending medical lawsuit. • Subjects with any inflammatory disease that may potentially increase C-reactive protein. • Subjects with any mental disorder which disables their comprehension. • Subjects with kidney stones or prone to develop kidney stones. • Subjects who have used depot hormonal contraceptives. • Subjects with history of addictions (e.g. alcohol, tobacco, illegal drugs, medications, compulsive gambling, etc.) which may interfere with the clinical trial or may not allow a correct monitoring.

Countries

Peru

Outcome results