Clinical trial NCT03918967: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Official title: A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 72
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:

* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
* Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
* Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) ≥18.0 and ≤30.0 kg/m2

Exclusion Criteria:

* Clinically significant allergic reactions
* Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
* Hepatic dysfunction upper limit of normal laboratory range
* Cardiac history or presence
* History or any concomitant active malignancy
* A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Inherited bleeding diathesis or coagulopathy with the risk of bleeding
* Hemoptysis, thrombotic or hemorrhagic event
* Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
* History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
* Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption

Primary outcomes:
measure: Incidence of Adverse events including serious Adverse events (Part I, Part II)
timeFrame: 46 days
measure: Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
timeFrame: Up to 48 hours after administration
Secondary outcomes:
measure: Safety parameters as assessed by: QT interval of ECG
timeFrame: 17 Days
measure: Safety parameters as assessed by: QTcF of ECG
timeFrame: 17 Days
measure: Safety parameters as assessed by: blood pressure of Vital signs
timeFrame: 17 Days
measure: Safety parameters as assessed by: pulse rate of Vital signs
timeFrame: 17 Days
measure: Safety parameters as assessed by: body temperature of Vital signs
timeFrame: 17 Days
measure: Safety parameters as assessed by: hematology of Clinical laboratory tests
timeFrame: 17 Days
measure: Safety parameters as assessed by: clinical chemistry
timeFrame: 17 Days
measure: PK parameters as assessed by : Area under the concentration-time curve (AUC)
timeFrame: 13 Days
measure: PK parameters as assessed by : Maximum observed concentration (Cmax)
timeFrame: 13 Days
measure: PK parameters as assessed by : Time to Cmax (tmax)
timeFrame: 13 Days
measure: PK parameters as assessed by : Terminal half-life time (t1/2)
timeFrame: 13 Days
measure: PD parameters as assessed by : Left ventricular ejection fraction (LVEF)
timeFrame: 17 Days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang
role: PRINCIPAL_INVESTIGATOR
References: