NCT03714568

Pharmacokinetic and Tolerance Study in Healthy Participants: a Single-centre, Randomized, Double-blind, Placebo-controlled Trial

Status unknown Phase 1 Last updated 9 December 2018

What this trial tests

Phase 1 trial testing TQ-A3326 in Pharmacokinetic in 60 participants. Status unknown.

Timeline

11 November 2018

Primary endpoint
1 September 2019

1 September 2019

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	60
Start date	11 November 2018
Primary completion	1 September 2019
Estimated completion	1 September 2019
Sites	1 location across China

Drugs / interventions tested

• TQ-A3326 — full drug profile →
• placebo

Conditions studied

• Pharmacokinetic — all drugs for Pharmacokinetic →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with Pharmacokinetic. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Serious Adverse Events (SAEs).
  Time frame: Day 1 up to Day 7 for non-SAEs .
  SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
• Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements.
  Time frame: Day 1 up to Day 7 or Discharge.
  Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the
• Number of Participants With Marked Abnormalities in Laboratory Findings.
  Time frame: Day 1 up to Day 7.
  Laboratory marked abnormalities were defined as Hematocrit (low) as \<0.85\*pre-treatment value, Leukocytes (low) as \<0.9\*lower limit of normal, Aspartate Aminotransferase (high) as \>1.25\*upper limit of normal, Creatinine (high) as \>1.33\*pre-treatment value, Bicarbonate (high) as \>1.2\*upper limit of normal, Total Protein (high) as \>1.1\*upper limit of normal, Creatinine Kinase (high) as \

Sponsor's own description

To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body；To study the transformation of TQ-A3326；To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.