RecruitingPhase 1ACTRN12614001240639

A study to determine the safety, tolerability and pharmacokinetics of ZYAN1 following oral administration in healthy volunteers.

A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYAN1, a novel PHD-2 Inhibitor, following oral administration in healthy volunteers.

Sponsor

Cadila Healthcare Limited

Enrollment

100 participants

Start Date

Oct 28, 2014

Study Type

Interventional

Conditions

Hypoxia related disorders Anemia

Summary

This is a first in man trial with ZYAN1. The primary aim of this study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics, pharmacodynamics, gender and food effect of ZYAN1 in healthy volunteers.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is the first human trial of a new experimental drug called ZYAN1. Researchers want to understand how safe the drug is, how it is absorbed and processed by the body, and whether food or gender affects how it works. Healthy volunteers (not patients) will be given carefully measured doses of the drug in a controlled setting, and their health will be closely monitored throughout. You may be eligible if: - You are a healthy adult between 18 and 65 years old - Your weight is above 55 kg and your BMI is between 18 and 30 - Your blood test results (including haemoglobin) are within normal ranges - You are able to use contraception during the study (if applicable) You may NOT be eligible if: - You have a history of significant illness (gut, respiratory, neurological, psychiatric, kidney, or liver conditions) - You smoke or have a positive cotinine test - You have recently donated blood or participated in another drug study in the last 3 months - You take prescription or herbal medications - You have had major surgery or illness in the last 3 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The interventional product, ZYAN1, will be administered as an oral tablet. The first part of the study (Plan I) is an single ascending dose (SAD) cohort (panel) design in which different patient pa

The interventional product, ZYAN1, will be administered as an oral tablet. The first part of the study (Plan I) is an single ascending dose (SAD) cohort (panel) design in which different patient panels will receive ZYAN1 1001 as a single dose. The starting dose in first panel will be 10 mg. Subsequent doses will be 25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg for panel 2, 3, 4, 5, 6 and 7. The subsequent panels will be conducted in new healthy males provided the previous panel is well tolerated. The second part of the study (Plan II) is a multiple ascending dose (MAD) cohort (panel) design in which different patient panels will receive the same single dose of ZYAN1 1001 on Day 1, Day 3 and Day 5. The starting dose in first panel will be x1 mg where "x" stands for starting dose which will be decided based on the results of the SAD study. Subsequent doses will be x2 mg, x3 mg and x4 mg for panel 2, 3 and 4. The subsequent panels will be conducted in new healthy males provided the previous panel is well tolerated. In the third part of the study (Plan III), ZYAN1 1001 will be administered once in fed and fasted conditions to healthy males and healthy females. The dose for this part will be decided based on the results of the first part of the study. The IP will be administered to the volunteer at site under the supervision of a trained study personnel. IP accountability will be documented in a log and verified by an unblinded monitor.